Regulatory Affairs

We offer the entire range of services of a registration department on the national and EU level. This includes assistance with registration procedures for chemically defined substances, biotechnology products and herbal medicines in all dosage forms and for all kinds of indications.

Evaluation of the odds for registration
Analysis of weak points in documentation
Bibliographical research
Expert reports / Overviews (CMC, preclinical and clinical studies)
Preparation of dossiers
Preparation of ready-to-submit registration documentation in the Common Technical Document (CTD) format
Support for registration procedures in all EU countries (MRP, decentralized and centralized procedures)
Reformatting of old documentation into the CTD format
Preparation of Investigational Medicinal Product Dossiers (IMPD)
Acting as applicant for drug registrations (on a national and EU level)

ADDITIONAL SERVICES:

Consultancy pertaining to strategic registration issues
Processing of all regulatory procedures handled by national authorities
Preparation of official texts in compliance with national legal requirements
Qualified Person according to the EU law available