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Event Invitation: LIVE BIOTHERAPEUTIC PRODUCTS – FROM EARLY DISCOVERY TO MANUFACTURING

Join us when we present on the topic of ‘Navigating the regulatory framework of LBPs from discovery through each stage of development’ at the MVA Microbiome network meeting on 15th December 2021 in Copenhagen. Sign up here.  https://lnkd.in/edm_Dxpy.

At this network meeting various experts will provide their insights on strategies and processes for developing and manufacturing of Live Biotherapeutic Products (LBPs) as well as provide clinical perspectives. Our international Microbiome expert Clara Desvignes will shed light on the complex regulatory environment. This is a physical event. 

 

IWAC Announces the Launch of Neighborhood programs for start-ups in the Nordics

IWAC Consulting, a dedicated group of regulatory science specialists in Denmark, has since 2019 been part of Voisin Consulting Life Sciences (VCLS), a leading global Regulatory Science consultancy company. Today we announce the launch of VCLS’ Neighborhood programs for start-ups in the Nordics.
Neighborhood is the first Regulatory Science focused innovation center that supports Life Science entrepreneurs, providing mentorship and access to regulatory specialists internationally. Since its inauguration in 2017, Neighborhood has supported more than 80 start-ups with over €90 millions raised. The goal is to support hundreds and thousands of entrepreneurs who are working to improve the health and wellbeing of everyone around the world.
IWA Consulting is happy to be able to support Nordic Start-ups through the Neighborhood programs. 

So, if you have a start-up within Medical/digital/Diagnostics, Drug Development or Gene/Cell Therapy, you can now get tailored regulatory mentoring, establish your product regulatory roadmap and broaden your network in the Nordics, Europe and USA through participation in the Neighborhood programs.
We offer Mentoring sessions, 12 months incubation program, as well as specialised programs focusing in USA Soft-landing and Market Access Strategy.
Through the program, start-ups will be guided on designing product development strategies that optimize clinical development and utilizes optimal regulatory pathways to drive commercial success in EU and USA.
“We are happy to launch the Neighborhood programs in the Nordics, to support the start-ups on their international journey, and being able to plug-in to a global start-up eco-system with a unique service offering giving access to highly specialized international regulatory expertise”, says Henrik Dörge, Business Development Director for Neighborhood activities in the Nordics.
IWA Consulting will be the anchor for the Neighborhood programs in the Nordics, providing access to the local specialized regulatory experts as well as the international expert team of VCLS. Having a local point of contact enables, hands-on support to start-ups in developing detailed plans and strategies and overcoming challenges on the way.
“We are excited to be able to utilise our local footprint, our global presence and our high level of regulatory expertise to make a difference for Life Science start-ups in an increasingly challenging regulatory environment through our involvement in the Neigborhood programs”, says Cécile Crozatier, Managing Director IWA Consulting ApS.

 

About IWA Consulting
IWA Consulting was founded in 1999 and provides highly specialized regulatory consulting services globally to both public and private clients in the biotech, MedTech and pharmaceutical industries. IWA Consulting is headquartered in Køge and has an office at COBIS, Copenhagen Bio Science Park. IWAC is part of VCLS group of companies, working together seamlessly as an extension of our client’s project teams, at an arm’s length, providing the resources and added value at time of need.
For more information, visit https://iwaconsulting.dk/

About VCLS
VCLS is a global Regulatory Science consultancy firm, which guides Biotechnology, Pharmaceutical and MedTech manufacturers throughout product development and market access. From early stage to patients, VCLS assists innovators by designing product development strategies that optimize clinical development to drive commercial success.
The firm offers integrated solutions with regulatory development strategy, chemistry formulation, manufacturing scale-up & control services, nonclinical & clinical regulatory development planning, clinical trial operations, safety monitoring, thanks to continuous interactions with regulators and payers. With offices in Cambridge, and Somerville (MA & NJ, USA), London (UK), Paris and Rennes (France), Lausanne (Switzerland), Copenhagen (Denmark) and Bangalore (India). VCLS serves a broad range of developers and investors in Life Sciences. For more information, visit www.voisinconsulting.com
About Neighborhood
Neighborhood is the innovation center of VCLS that supports HealthTech entrepreneurs, providing strategic mentorship and resources, experts, and office space for growth. It offers tailored in-residence mentoring, coaching and global access to HealthTech entrepreneurs. For more information, visit www.voisinconsulting.com/neighborhood

Media Contact:
Henrik Dörge
Business Development Director, IWAC
+45 9189 8040
hd@iwaconsulting.dk.

 

Voisin Consulting Life Sciences announces the acquisition of Quanta Medical

The transaction brings together two high-quality, innovative, and growing organizations with similar cultures and a shared commitment on high quality and efficient clinical trial protocol design and execution, from Phase 1 to post-approval studies.

Read how this acquisition will reinforce VCLS with a broaden foothold in the clinical operations space. 

New wave of digitization creates both opportunities and challenges

Few Life Science companies have sufficient specialized internal resources to deal with the extensive and complex regulatory requirements required by drug development and medical device development.
At the same time, modeling and simulation are becoming an increasingly important discipline in the efforts to optimize the decision basis for safety, efficacy, dosage and specific patient target groups.

Read how IWA Consulting views the opportunities and challenges that digitalisation creates.

 

Implementation of a more efficient automated Quality Management System

IWA Consulting has for year successfully provided regulatory specialist services to the biotech, pharma and pharmaceutical industries. Part of the success is based on establishment of an ISO9001 certified Quality Management System in supporting efficient and high quality regulatory services, and with the purpose to further build on our mission to provide scientifically grounded state of the art assistance and guidance by mastering quality, safety and efficacy in managing global regulatory affairs, IWA Consulting has decided to implement a more efficient and automated Quality Management System.

Read more https://www.it-relation.com/about-us/cases/iwa-consulting

Change of Managing Directors of IWA Consulting ApS

As of March 1, 2021, Cécile Crozatier will become the new Managing Director

July 2019, IWA Consulting joined forces with Voisin Consulting Life Sciences and became part of the VCLS family. By this change, the next step in the history of IWA Consulting (IWAC) was taken to further strengthen IWA Consulting’s capabilities and business. Now the time has come to change Managing Directors of IWA Consulting.

We are happy to inform you that as of March 1, 2021, Cécile Crozatier will become the new Managing Director of IWA Consulting. Cécile Crozatier possesses huge science and managerial competencies making her the right successor of Connie Lyngbek Thestrup and Lillan Rejkjær.

By training, Cécile Crozatier is a scientist and has over 15 years’ experience in academic research, pharmaceutical industry, technology transfer, and alliance management. Prior to joining IWAC Cécile Crozatier gained a strong background in Alliance Management and Business Development through multiple commercial positions in the industry where she developed a sharp-minded approach to negotiation, contractualization, and implementation through working on a large variety of transactions.

Cécile Crozatier is still contributing to scientific work and has over the past years actively contributed to the development of Computer Modelling and Simulation (In Silico medicine) capabilities as well as successfully lead transformational projects within the VCLS group.

IWA Consulting will continue with the same profile, and values of trust, integrity, and quality moving forward with Cécile Crozatier as Managing Director, no other changes are implemented in the organisation. Your usual point of contacts and consultants are in place and ready to further assist you.

Former Managing Directors, Connie and Lillan, will continue for a period as strategic advisors and members of IWAC’s board.
We continue to build on the expertise of our regulatory and medical knowledge to make our client’s products successful. For IWAC, it will always be about our client’s needs, with the focus on added value to their projects.

 

 

An audit performed as a remote audit – why not?

The current Covid19 situation calls for alternative solutions, out-of-the-box thinking, and new ideas on how to manage day-to-day activities. A lot of activities which in the past normally would imply individuals to meet physically have called for alternative solutions since the start of the pandemic. However, some are concerned whether this is adequate when it comes to performing audit activities. Our experience shows that remote audits are just as efficient and even brings added value to the audit if you just consider a few things.

For years IWA Consulting has offered and delivered different audit services to our clients. Either mock-up audits in the process of preparing for Notified Body audits or formal internal audits when clients are lacking internal resources to manage on their own or to manage other audits concerning e.g., ISO13485, MDSAP, MDR. Normally these audits have been done on-site at the client’s premises. However, to provide more flexibility and to meet the need for safety for our clients and our internal experts, we have decided to offer and strengthen our ability to perform remote audits.
Attending and managing virtual meetings, webinars, etc. has in general increased the acceptance and taught us how to work efficiently together remotely and share information electronically. Consequently, in many ways, remote audits are no longer any different from the meetings and activities, which many of us normally manage.

IWA Consultings approach for remote audits has been quite the same as for on-site audits before Covid19. The keyword being thorough planning and alignment with the client. The preparation includes creating a clear audit agenda to specify the scope, the subjects and timeline including timeslots for opening and closing meetings, not to forget breaks throughout the audit. This will allow the auditee to organize well and ensure that the right experts are available as needed.

Another important twist in the planning is to agree on the electronic communication set-up and verify that the chosen set-up functions effectively and as expected prior to the audit.

Studies have shown that more than 50% of the communication between individuals consists of body language, meaning the ability to see each other and “read” the face and body during communication. As such, this is something to consider when using virtual meetings in general. Having that in mind, a setup during audit providing the flexibility to both assess documents and have discussions using video feature at the side has shown to be quite efficient as it also involves body language communication.
A challenging element will be to audit physical aspects like production or stock areas and facilities. Auditing these aspects also requires some alternative solutions, but with the right approach and e.g. use of the cell phones video features, etc. the auditor can to some degree “remote control” a representative from the auditee to provide real-time video of facility during the audit.

In conclusion remote audit has proven to be a quite powerful, flexible, and sometimes even less expensive way to perform audits.
In case you would like to learn more about how IWA Consulting can support your organization with audit services, please feel free to contact Johnny Hansen, +45 5154 5520, jh@iwaconsulting.dk.

 

Need help you to deal with the regulatory challenges? We know how to deal with these.

It’s fair to say that the medical device industry has struggled significantly with regulatory challenges over the last years. Implementation of MDR/IVDR, establishment of Medical Device Single Audit Program (MDSAP), needs to adopt the revised quality management standard (ISO/EN 13485:2016) and – as for most industries – the challenges derived from Brexit and COVID-19, just to mention a few.

Discover how we help you to solve these challenges in our article in Medical Technology https://pharma.nridigital.com/pharma_nov20/iwa_consulting_company_insight

When you start – start right – read our article in the magazine Pharma Technology Focus

 

Regulatory Affairs is a big challenge for many Life Science Companies. By actively focusing on Regulatory Science and Digitisation of the Marketing Authorisation application as early in the development phase as possible, companies gain time and minimise the risk of potentially fatal errors. By involving regulatory consultancy companies – like IWA Consulting – at as early a stage in the process as possible, life science companies benefit significantly.

Read more https://pharma.nridigital.com/pharma_nov20/iwa_consulting_company_insight

We perform our tasks based on our long-term regulatory experience, in-depth knowledge, and expertise.

The IWA Consulting Team is a dedicated group of regulatory science specialists providing expert services to a range of international private and public clients. We perform our tasks based on our long-term regulatory experience, in-depth knowledge, and expertise.

We assist biotech, pharma, and medical device companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory science – in every aspect of the discipline – is our core competence. Discover more : https://pharma.nridigital.com/pharma_nov20/iwa_consulting

Market Access

How to obtain successful market access for a pharmaceutical product?

Pharmakon is hosting an online “stay-home-meeting” with IWA Consulting as speaker, 16th November 2020, on “How to obtain successful market access for a pharmaceutical product?”. Based on presentations on regulatory and market access processes and how they interrelate we will discuss the challenges to obtain successful market access of a pharmaceutical product. Please register here: https://www.pharmakon.dk/kurser/life-science/gaa-hjem-moede/

2020-10-28

EMA advice on Nitrosamines

As of September 2019, EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

As of July 2020 EMA, extended the scope to include biological products.

Step 1 – Risk Evaluation:

MAHs should perform risk evaluation of their medicinal products containing chemically synthesized APIs.

MAHs should prioritise products in order to establish the sequence in which their products are to be evaluated. For products identified as high priority, the risk evaluation should be done immediately.

The risk evaluation of all products should be concluded at the latest within 6 months of the publication of the EMA notification. MAHs should inform the concerned Competent Authorities when the risk evaluation is concluded. Risk evaluation documents do not need to be submitted but should be made available upon request. If a risk of presence of nitrosamines is identified as a result of the evaluation, the MAH should proceed to Step 2.

The deadline to complete Step 1 for chemical medicines has been extended to 31st March 2021.

The deadline to complete Step 1 for biological medicines: 1st July 2021

Step 2 – Confirmatory testing:

If a risk of presence of nitrosamines is identified as a result of the risk evaluation, confirmatory testing should be carried out using appropriately validated and sensitive methods in accordance with the prioritisation deriving from the risk evaluation conducted in Step 1. Products identified as high priority should be tested as soon as possible.

Confirmatory testing of all medicinal products identified to be at risk of presence of nitrosamines and submission of required changes in the manufacturing authorisations should be concluded at the latest within 3 years of the publication of the EMA notification or at an earlier time if otherwise justified.

MAHs should inform the competent authorities immediately if tests confirm the presence of a nitrosamine impurity irrespective of the amount detected.

Step 3 – Changes to the marketing authorisation:

MAHs should apply for a variation in a timely manner to introduce any required changes, such as amendment of the manufacturing process or changes to product specifications.

At all steps, timelines should be shortened, and authorities immediately informed if findings indicate an immediate risk to public health.

Deadline: Confirmatory testing activities (Step 2) and any changes required for the marketing authorisations (Step 3) is 26th September 2022 for chemical medicines and 1st July 2023 for biological medicines.

Let IWA Consulting handle the submissions during Step 1 and Step 3:

The IWA Consulting Team can assist you with the submission(s) of your conclusion(s) of your Nitrosamine Risk Evaluation (Step 1) and the Changes to the marketing authorisation (Step 3). Feel free to contact us to discuss your specific needs.

2020-10-28

Health Canada’s Regulatory Enrolment Process (REP) – Mandatory from 1st October 2020

Are you prepared for Health Canada’s Regulatory Enrolment Process (REP)?

Heath Canada (HC) has introduced a new process for the filing and processing of regulatory submissions titled the Regulatory Enrolment Process (REP). This process is a step towards harmonising transactions across a broad range of regulatory transactions made via the Common Electronic Submission Gateway (CESG).

The REP consists of both the enrolment of company and contact information, as well as the use of web-based templates to generate XML files. These XML files are submitted to Health Canada via the CESG and replace some older forms.

Currently, the web-based templates collate information relating to company information, regulatory transactions, product information and fees. Sponsors are required to complete some initial registration steps before submission can be made and we strongly recommend that these are done well in advance of any upcoming submission deadline.

From 1st October 2020, the use of the REP for Human Use Drugs is mandatory. The new requirements encompass both eCTD and non-eCTD formats and for the moment are only applicable for Medicinal products intended for use in Humans. The project is set to expand to Medical devices, Clinical Trials, Veterinary Drugs and Master files into the future.

Do you have a product registered in Canada and need assistance with Health Canada’s regulatory environment? IWA Consulting are very happy to assist you with any regulatory challenge.

2020-10-21

Scientific Advice platform

As of October 19, Scientific Advice with the EMA must be applied through the IRIS portal. If you need any assistance on this new portal – or with Scientific Advice in general, we can help you!

Do you want to know more take a look at EMAs website https://www.ema.europa.eu/en/news/new-online-platform-scientific-advice

2020-10-16

Switzerland – The Authorisation of human medicinal products under Article 13

Do you currently have a medicinal product on the market within the EU? Expanding the market into Switzerland can be an easy way to increase the availability of your medicinal product.

The health authority of Switzerland, Swissmedic, offer a special marketing authorisation application procedure for products authorisation in the EU. The marketing authorisation is applied for under “Article 13, Medicinal products and procedures authorised in foreign countries”. This procedure must fulfil a few specific procedure conditions but has less requirements relating to documentation than a full marketing authorisation application as it allows much of an existing EU dossier to be easily repackaged and submitted, and it may even lead to an earlier decision. The reduced regulatory burden of this application type means that expanding into Switzerland can often be an efficient way to expand the marketing potential of a product currently authorised in the EU.

We have recently been very successful in assisting our clients in expanding their EU market into Switzerland under article 13, using our knowledge of the Swiss regulatory and eCTD/publishing requirements.

IWA Consulting’s experience and our network of experts in the VCLS family, allow us to provide comprehensive advice relating to regulatory strategy and expanding market opportunities. We are always happy to have a discussion about your product’s marketing potential, the best way to approach regulatory hurdles or other areas within the regulatory world.

2020-09-17

Read our article ‘WHEN YOU START – START RIGHT’ in The magazine ‘Life Science’ here

Life Science is included in the Danish Newspaper Berlingske today.

2020-09-15

How to overcome the regulatory challenge due to BREXIT

Pharmakon is hosting an online “stay-home-meeting” with IWA Consulting as main speaker, 9th September 2020, on “how to overcome the regulatory challenges due to BREXIT”. The meeting will discuss the impact of Brexit on medicinal products – in the pre-and post-approval phase. Please register here. ‘Stay-home-meeting’

Implementation of Medical Device Regulation MDR 2017/745 postponed – so what’s next?

As communicated in many medias recently, the European Parliament have decided to postpone the implementation of MDR 2017/745. Consequently, the originally schedule to go into effect May 26, 2020, will now take effect May 26, 2021.

It’s fair to say that the EU Medical Device Regulation (MDR) has been a source of stress for the medical device industry, and trade association like MedTech Europe as well as individual members of the European Parliament have at different occasions encouraged the EU Commission to reconsider to postpone the Medical Device Regulation implementation date. COVID19 has significantly transformed many things, and there is a huge demand for the national health authorities and medical device manufactures to accommodate the need of providing medical devices to fight COVID19.

This situation could potentially compromise the supply and availability of needed medical devices to fight COVID-19, considering the challenges for the medical device industry to simultaneously transition into the new Medical Device Regulation.

Consequently, the European Parliament have now voted to postpone the implementation of Medical Device Regulation by one year to allow authorities and manufacturers to prioritize the fight against the COVID19 pandemic.

Besides the positive effect of reducing obstacles for the continuous supply and availability of needed medical devices to fight COVID-19, the changed situation allows medical device companies to revisit existing plans and activities initiated to update, revise and close identified gabs to document MDR compliance related to quality management systems (QMS), structure and content of medical device technical documentation file, PMS, etc., as one more year has been allowed to “get the work done”.

Adequate and timely revisit of plans and activities should be done taken into consideration the experiences gained so far, with the purpose to avoid medical device manufactures to end in a similar stressed situation when the Medical Device Regulation gets implemented in May 2021.

IWA Consulting ApS is capable in supporting your company in the process of preparing for the implementation of the Medical Device Regulation, both in terms of providing consultancy services in preparing your regulatory strategy, assess you quality management system, compilation and submission of technical documentation file and interaction with Notified Bodies.

2020-05-07

Do COVID-19 affect your medicinal product?

With Health Authorities busy focusing on the COVID-19 crisis and isolation measures in place around the world, regulatory procedure timelines and management of clinical trials have been drastically challenged. Recommendations and guidelines are changing rapidly.

IWA Consulting’s parent company Voisin Consulting Life Sciences (VCLS) has a great webpage dedicated to the emerging regulatory developments caused by the COVID-19 crisis. You can find the guide here: https://voisinconsulting.com/expertise/vcls-covid-19-update.

Do you have questions about how the COVID-19 crisis is affecting your medicinal product? The IWAC team are always ready to assist with any questions and tailor a solution that matches your needs.

2020-04-15

Read our article about Identifying the Competitive Edge in The magazine ‘Healthtech’ here.

Healthtech is included in the Danish Newspaper Børsen today.

2020-03-31

Read our article about Identifying the Competitive Edge in Greater Copenhagen Life Science Yearbook 2020 here.

2020-03-13

Health Canada implementation of eCTD for clinical trial regulatory activities

Health Canada has announced that the pilot for Clinical Trial regulatory activities in eCTD format was successful. Therefore, implementation of Clinical Trials regulatory activities in eCTD format will begin immediately.

Health Canada Notice: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-implementation-ectd-clinical-trial-regulatory-activities.html

We can help and guide you through your Health Canada Clinical Trial regulatory activities. Visit our homepage for further information about IWA Consulting’s services.

2020-03-04

Orphan Drug – FDA moving towards an online system for submission of orphan drug designation requests

FDA has announced that orphan drug designation requests will be accepted via an online portal later in 2020. The portal is also expected to facilitate more direct communication between sponsors and the FDA.

FDA announcement: https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-harnesses-technology-and-collaboration-support-rare-disease-product-development

RAPS post: https://www.raps.org/news-and-articles/news-articles/2020/1/fda-to-allow-electronic-submissions-of-orphan-desi

We can help and guide you through your orphan drug designation request. Visit our homepage for further information about IWA Consulting’s services https://iwaconsulting.dk/ .

2020-02-07

Merry Christmas and Happy New Year

We all at IWA Consulting wish you a very Merry Christmas and a Happy New Year.

Thank you for the collaboration in 2019 and we look forward to the challenges that 2020 will bring.

2019-12-12

 

Are you going to CPhI Worldwide?

IWA Consulting will be present at the event and we would very much enjoy having a chat with you. Both Managing Directors, Lillan Rejkjær and Connie Thestrup, will be there Tuesday and Wednesday. If you are interested in having a chat with us, please send a mail to info@iwaconsulting.dk and let’s schedule a meeting.

We hope to see you there.

2019-10-16

IWA Consulting is attending the TOPRA Symposium 2019 in Dublin 30 Sep – 2 Oct 2019.

TOPRA Annual Symposium 2019

2019-10-01

Are you going to CPhI Worldwide?

IWA Consulting will be present at the event and we would very much enjoy having a chat with you. Both Managing Directors, Lillan Rejkjær and Connie Thestrup, will be there Tuesday and Wednesday. If you are interested in having a chat with us, please send a mail to info@iwaconsulting.dk and let’s schedule a meeting.

We hope to see you there.

2019-08-29

1 October 2019 eCTD becomes mandatory for all National Procedures in Denmark

As of 1 October 2019, eCTD becomes mandatory for all regulatory activities in National Procedures (NP) for human medicinal products in Denmark according to Danish Medicines Agency “Format requirements for applications for authorisation of medicinal products”

We can guide and assist you in the transition from submission in paper or NeeS format to submission in eCTD.

Feel free to contact us for a talk about your challenges or visit our homepage for further information about IWA Consulting’s services.

2019-08-21

To Marketing Authorisation Holders of a medicinal product with an integral medical device

New requirements for the device part of your medicinal product based on medical device regulation 2017/745, article 117 “Amendment to Directive 2001/83/EC”  may impact on your future submissions.

We recommend that you contact your device manufacturer to ensure that they have the required documentation updated.

EMA has published a Q&A “Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)” with focus or the impact of article 117.

If you need advice, please contact IWA Consulting where you can meet both medical device and pharma experts.

2019-07-30

IWA Consulting joins forces with Voisin Consulting Life Sciences (VCLS) – read the press release here.

2019-07-10

Transition from a manual paper-based Quality Management System to an electronic Quality Management System

In our aim to create more value for our customers IWA Consulting has over the last months transferred our paper-based Quality Management System to an electronic SharePoint based solution (eQMS). The implementation is expected to reduce time-consuming workflows and minimize the risk of mistakes enabling our consultants to focus on performing our customer’s projects with high quality.

Benefits of the transition:

  • Easy and fast access to QA documents for all employees
  • Easy way to update and implement QA documents
  • Easy way to sign off for reading QA documents
  • Environmentally friendly – reduce the amount of paper used

2019-06-28

Successful annual follow up audit against ISO 9001:2015

IWA Consulting strive to continuously ensure all our clients a consistent high level of quality covering all aspects of our services, we are therefore proud to announce that we have successfully undergone our annual follow up audit against ISO 9001:2015.

2019-06-24

Read our article ‘WHEN YOU START – START RIGHT’ in The magazine ‘Life Science’ here

2019-06-06

IWA Consulting’s own, Lillan Rejkjær, describes the importance of planning regulatory work properly right from the start, in Norway’s Dagens Næringsliv. Read what Lillan and seven other experts consider the most important issues for the Life Science industry: Analyse Life Science

2019-05-10

 

IWA Consulting will be on our yearly company seminar 2nd and 3rd of May

Once a year IWA Consulting spend 2 days away from office to further expand our competencies, regulatory intelligence and knowledge to increase customer benefit and satisfaction. This year’s company seminar will take place from 2nd to 3rd of May. We will of course be reachable as always and answer the phone in case of urgency.

We look forward to providing our services to you with renewed energy and motivation when back in office again Monday 6 May.

2019-05-01

IWA Consulting is attending the DKMA meeting on Tuesday April 30th on complex clinical trials.

https://www.linkedin.com/feed/update/urn:li:activity:6526424599247355905

2019-04-30

IWA Consulting is giving a lecture at Atrium Regulatory Affairs Module 10 Biopharmaceuticals, April 3 – 5, 2019.

Topic:

REGULATORY CMC STRATEGIES IN THE EU DURING DEVELOPMENT.

Margrethe Erbou Andersen

Head Regulatory Development and Compliance

IWA Consulting ApS.

2019-04-05

Read our article about Incorporating Clinical Trials in Global Regulatory Files in Greater Copenhagen Life Science Yearbook 2019 here.

2019-03-14

Free download of template for Medical devices

The free download “GSPR MD” General Safety and Performance Requirements template for Medical devices, has been updated with minor changes to version 03. Get a free copy here.

2019-03-01

New concept for National Scientific Advices introduced

Are you aware, that the Danish Medicines Agency has introduced a new concept for National Scientific Advices? Please check out the details on the link below, or contact IWA Consulting for assistance on how to conduct Scientific advice meetings with the Danish Medicines Agency. https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/marketing-authorisation/scientific-advice-on-development-of-medicinal-products/

IWA Consulting is also able to assist your company with conducting Scientific Advices with other national agencies in the EU, with EMA or with the US FDA. Call Head of Regulatory Development & Compliance Margrethe Erbou Andersen at +45 3043 0979 for an informal talk on your development project.

2019-02-27

eCTD is now mandatory for National Procedures (NP)

We’ve earlier announced that eCTD became mandatory January 1st 2019 for NP. Following up on that, please be advised that the eSubmission expert group recently published Q&A on mandatory eCTD in National Procedures (NP) on their homepage: https://lnkd.in/eNksruj

It should be noted that: The change to eCTD format for a NP purely product dossier should normally be done at the start of a new regulatory activity (e.g. a new variation application), so ongoing procedures should be continued in the same format as the starting submission, as long as no new regulatory activity is started in parallel after 1 January 2019.

2019-01-16

Falsified Medicines Directive (FMD) – Deadline 9 Februry 2019

As of 9 February 2019, prescription medicines released to the EU and EEA markets must carry the safety features: unique identifier (UI) and anti-tampering device (ATD). Several medicinal products are, however, exempt from this rule. These are listed in Annex I of the Delegated Regulation (EU) 2016/161 here: https://lnkd.in/dquwCUh. Greece and Italy are exempt from the 9 February 2019 deadline and will implement by end of 2019 and in 2025, respectively. Feel free to contact us for a talk about the challenges that the Falsified Medicines Directive presents and how it may affect your product. 

2019-01-03

IWA Consulting is participating in LORENZ UserBridge18 Conference 18-20 September 2018

IWA Consulting is pleased to participate in the LORENZ UserBridge18 conference in Prague, Czech Republic, this September. Senior eSubmission Manager Helle Ørbæk and eSubmission Manager Harry Milan will spend the week gaining knowledge of cutting-edge eSubmission strategies allowing IWA Consulting to continue to provide innovative and efficient regulatory solutions to any global eSubmission issue.

IWA Consultings Medical Device services are now also included in our ISO 9001:2015 certification

IWA Consulting is proud to announce that the scope of our ISO 9001:2015 certification has been expanded to include our Medical Device services. This milestone emphasizes our ambition to deliver regulatory and medical affairs services of the highest quality to all our customers.

We can assist your company with a wide range of both regulatory and quality management tasks in the Medical Device area.

Feel free to contact our Medical Device RA & QA Specialist Louisa Memborg at +45 5666 0490 for a talk about your challenges.

2018-06-28

Børsen has distributed their latest insert Analyse Industri focusing on life science.

Lillan Rejkjær from IWA Consulting is part of the expert panel discussing the process optimization for bringing new medicinal products faster and safer to the market.

You can read the complete panel discussion here. https://issuu.com/europeanmediapartner/docs/analyseindustri_0618_e-paper

To know more about IWA Consulting please visit www.iwaconsulting.dk

June 2018

Meet us at DDF Summit 12 – 14 March in Berlin

You are very welcome to book an informal meeting with our participants where you can discuss various regulatory challenges with combination products:

Camilla Wamberg Munkesø – Head Medical Device RA & QA

Margrethe Erbou Andersen – Head RA Quality

COBIS seminar held 24th January 2018

Thanks to those who participated at our COBIS seminar on drug/device combination products.

We had some good discussions.

For those interested –  have a glance at our presentation here – we hope to see you next time!

See the presentation here.

Afternoon SEMINAR on drug/device combination products 24th January 2018.

See the invitation here.

New Regulatory Affairs Specialist

We’re happy to announce that Marianne Vinther Ammitzbøll is joining our Regulatory & Medical Development team. Marianne has more than 10 years experience within Regulatory Affairs, primarily within development and life-cycle management of biological products. Lately Marianne worked as RA CMC specialist at AJ Vaccines, RA development documentation including CMC will be Mariannes primary tasks at IWA Consulting.

Marianne already started the 1st of December – please welcome her to IWA Consulting.

Prepare for the future legal
framework for clinical trials in Europe

Read Lillan Rejkjær’s post in Greater Copenhagen Life Science Magazine on how we at IWA Consulting assist our clients understand the process to choose a regulatory pathway from the very beginning here.

IWA Consulting – 20 years with Regulatory Affairs Consultancy

20 years have passed and much has happened since we began our journey up the ladder. It all started in 1997 being a one-man company, and have now grown to be 20 fantastic employees, always ready to take on any challenge with new clients and tasks. Looking back, our journey is full of fun and memories, but what is more important is looking forward at the next years to come. It’s important for us to keep growing and expanding our fields of expertise; latest we have expanded with a team of Medical Device RA specialists. We believe that the opening of our office at COBIS will bring us closer to the start-up community and will strengthen our competitiveness and help innovate our services to best fit our clients’ needs and regulators’ demands. No task is the same and all have been challenging at different levels and all have added new expertise and experience to our competencies. Thank you to everyone having been part of our journey! We’re looking forward to keep cooperating and welcoming new clients and projects.

 

FDA DMF eCTD Compliance date postponed to May 5, 2018

On April 7, 2017, the FDA announced that it is extending the compliance date for submitting drug master files (DMFs) in electronic common technical document (eCTD) format by one year to May 5, 2018.

Reflecting this; FDA has released Revision 4 of the Guidance “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document (eCTD) Specifications”.

The compliance date for submitting NDAs, BLAs, ANDAs and INDs electronically remains unchanged.

For further information please refer to FDA Drug Master Files (DMFs) website.

If you want to stay updated on the eCTD implementation progress, then follow IWA Consulting and we will keep you updated at our Linkedin page.

New Product Information Specialist

In April 2017 IWA Consulting has welcomed Simone Grundtdal Skat Ancker to the Regulatory & Medical Development Team. Simone purses a Master of Science in Molecular Biology and has worked with regulatory affairs documentation and filing. In the Regulatory & Medical Development Team she will assist our clients with Product Information, Labelling and Regulatory Marketing Material Approvals.

For more information about our IWA Consulting expert services, please contact Head Regulatory & Medical Development, Lillan Rejkjær or visit www.iwaconsulting.dk.

 

 

Centralized Procedures Ahead for CTAs

The Medicon Valley Yearbook 2017 has just been published and our partner Lillan Rejkjær shares how the future of eCTD will embed all RA activities including Policy 0070 and marketing material.

The eCTDs is here to stay and can optimize the process of filing for a marketing authorization with both the EMA and the FDA, simultaneously.

“Integration of eCTDs is not easy at all, but I assure that it is a whole lot easier – and quicker – if the eCTD mindset is introduced upfront instead of when the regulatory people is compiling the marketing authorization application.” says Lillan Rejkjær.

You can find the whole article here at page 34-36.

New Head of our RA Quality Team

As of 1 January 2017 we welcome Margrethe Erbou Andersen as Head of our RA Quality Team. She will be heading a group of regulatory affairs specialists with expertise in Quality regulatory affairs.

Our Regulatory Affairs Quality team takes care of:

  • managing variations in the EU or amendments/supplements in the US
  • handling M2.3 and M3 documentation
  • providing early stage development consultancy
  • preparing applications for registration of Certificates of Suitability (CEP) with EDQM as well as ASMFs for drug substances in eCTD format

For more information about our RA Quality team and our expert services, please contact Margrethe Erbou Andersen.

Business Presentation of IWA Consulting in Nordic Lifescience Magazine – Read here

New General Management

We are happy to announce that as of March 27’th, 2015 IWA Consulting is owned and managed by the two Managing Partners Lillan Rejkjær and Connie Lyngbek Thestrup. Read more here.