HBP Regulatory services

We provide the following services:

Obtaining marketing authorisation of medicinal products (national procedure, DCP/MRP, RUP, centralised procedure)
Obtaining parallel import/distribution marketing authorisation of medicinal products (national procedure, centralised procedure)
Post authorisation procedures (renewals, type IA, IB and II variations, other changes:
changes in classification of supply, products line extensions).
Registration & notification of medical devices
Registration & notification of food supplements and foods for special medical purposes
Notification of cosmetic product
Additional services :

Technical, Pharmaceutical and Medical writings:
RMPs, PSURs
Quality, Clinical and Non-clinical Overviews and Summaries
Other Dossier documents
Regulatory and Medical Review of Promotional Materials
Price Declaration and Reimbursement applications