HERMES PHARMA's Drug Regulatory Affairs experts help you to clear all the hurdles on the journey to regulatory approval for existing or newly developed products. We support our customers with finding the most suitable registration strategy for the products we develop and manufacture.
Our expertise includes medicinal products, food/dietary supplements and medical devices. We support your marketing authorization applications e.g. under Directive 2001/83/EC articles 10(1) (generic applications), 10(3) (hybrid applications) and 10a (well-established use applications), by coordinating and managing the entire marketing authorization, or by providing the required parts of it.
Our highly experienced pharmacists and chemists offer the following services for National (NL), Decentralized (DCP) and Mutual Recognition (MRP) Procedures:
- Compile up-to-date marketing authorization application dossiers in eCTD format (electronic Common Technical Document) for medicinal products
- Plan and conduct Mutual Recognition Procedures (MRP) and Decentralized Procedures (DCP) and support with National Procedures (NL)
- Prepare all quality-related content of the application dossier for all HERMES PHARMA medicinal products in eCTD-compatible format (CTD Modules 1.4.1, 2.3, 3, and further supporting documentation for Module 1)
- Organize expert reports (CTD Modules 2.4, 2.5, 4.3, 5.4)
- Address assessment reports and deficiency letters from authorities
- Compile data packages for variation applications
- Ensure regulatory compliance of marketing authorizations for your medicinal products throughout their lifecycle
- Guarantee compliance with current ISO norms and readiness for the new Medical Device Regulation
- Provide quality documentation for your food/dietary supplements according to your specific needs
Covering all your regulatory needs
Our regulatory services cover the entire regulatory lifecycle from initial application to post-approval activities. For medicinal products we can either supply single CTD parts when customers wish to handle the marketing authorization themselves, or we can conduct the entire registration procedure on behalf of the customer.
We involve our regulatory experts in the research & development phase to ensure that the later registration processes run quickly and cost-efficiently. It's this holistic approach that allows us to get our customers' products to market faster.