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How to overcome the regulatory challenge due to BREXIT

Pharmakon arrange ‘Gå hjem-møder’ at their location in Hillerød and IWA Consulting is invited to hold a presentation on the regulation challenge due to BREXIT 24. June 2020 at 5 -7 pm.

Please join the ‘Gå hjem-møde’ for agenda and sign up.

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.


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.


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

Healthtech is included in the Danish Newspaper Børsen today.


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


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.


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/ .


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.

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.

Deadline: within 6 months of the publication of the EMA notification i.e.


UPDATE: The deadline to complete step 1 has been extended to 1 October 2020.

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.

Deadline: within 3 years of the publication of the EMA notification i.e. 26.09.2022.

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: within 3 years of the publication of the EMA notification i.e. 26.09.2022.

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.


  1. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-information-nitrosamines-marketing-authorisation-holders_en.pdf
  2. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-information-nitrosamines-marketing-authorisation_en.pdf
  3. https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Advice_from_CMDh/Nitrosamins/CMDh_412_2019_Rev.2_2019_12_clean_-_PG_to_MAHs_on_nitrosamines.pdf
  4. https://www.ema.europa.eu/en/documents/press-release/ema-advises-companies-steps-take-avoid-nitrosamines-human-medicines_en.pdf


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.


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.


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

TOPRA Annual Symposium 2019


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.


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.


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.


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


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


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.


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


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


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.


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



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



Margrethe Erbou Andersen

Head Regulatory Development and Compliance

IWA Consulting ApS.


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


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.


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.


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.


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. 


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.


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.