REGULATORY SERVICES
Our Drug Regulatory Affairs team helps you to clear all of the hurdles on the journey to regulatory approval. We advise on the most effective regulatory approval strategy for each individual product – be it a medicinal product, food or dietary supplement or medical device.
Our highly experienced pharmacists and chemists:
- Compile up-to-date application dossiers and registration documents according to the latest EU directives and specifications such as CTD for going eCTD (electronic Common Technical Document) or NeeS (Non-eCTD electronic Submission)
Contact Us
Hermes Arzneimittel GmbH
Division HERMES PHARMA
Georg-Kalb-Strasse 5-8
82049 Pullach
GERMANY
Phone +49 89 79102 261
- Plan and manage national and EU registration procedures such as Mutual Recognition Procedures (MRP) and Decentralized Procedures (DCP)
- Address assessment reports and deficiency letters from registration authorities
- Compile CMC data packages (Chemistry Manufacture Control) for variations
- Plan and organize bioequivalence studies in collaboration with Contract Research Organizations (CROs)
Our regulatory services cover the entire regulatory lifecycle - from initial application to post-approval activities. We can manage registration procedures in the name of the client or register under our own name and transfer the resulting marketing authorizations afterwards.
Our regulatory experts are involved in the research & development phase from the outset, ensuring that the registration process runs quickly and cost efficiently so that our clients can get new products to market rapidly.