Gå til indholdet

Regulatory & Medical Development

Headed by Lillan Rejkjær, the Regulatory & Medical Development Team consists of regulatory affairs specialists with considerable expertise.

The R&M Development team

  • Regulatory & Medical Developmentdevelops 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.