Headed by Lillan Rejkjær, the Regulatory & Medical Development Team consists of regulatory affairs specialists with considerable expertise.
The R&M Development team
- develops regulatory strategies and provides early stage development consultancy
- prepares for scientific advice with authorities
- prepares (e)CTA, eIND, and PIP applications
- prepares Orphan drug designation requests
- prepares ATC code applications
- produces product information texts (core English versions as well as national texts)
- prepares SME applications
- prepares CCSI / CCDS
- provides pharmacovigilance and DSUR/PSUR services
- handles the M2.4-2.5 and M4-5 documentation (review, writing etc.) of MAAs, NDAs, and ANDAs
- support launch strategies including marketing material, catalogue texts, pricing, and reimbursement
- provides assistance with medical device on quality systems, classification evaluations, Conformity Assessment Procedures,CE marking and finally preparation of dossiers to Notified Bodies and other relevant parties
For more information about R&M Development services, please contact Lillan Rejkjær.