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