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