Drug Reg. Aff.

Drug Regulatory Affairs:


Our services in the field of Drug Regulatory Affairs essentially include:


Medicinal product marketing authorisations / Articles 8(3) and 19 (a, b, c) of Regulation 2001/83EC).


– Centralised and decentralised European marketing authorisation procedures (CP, DCP / MRP, NP)
– Variations
– National phase, translations
– Product information texts
– Communication with national authorities
– Advice on regulatory strategy

Submissions

– Document review
– Submission
– Defect handling

Alert Management in NMVS

– Alert management
– Contract initiation with the required suppliers
– Trouble shooting

IFA notifications (PZN)

– Customer registrations
– PZN new admissions
– Price changes