Regulatory Affairs Service
Your product should be launched as quickly as possible? It is already on the market and must be continuously maintained? Or you would like to discuss with someone the practical expansion of your product portfolio.
You need someone to assist you in thinking ahead in your own interest and offers you specialised assistance where your own resources are scarce? Then start a dialogue with us.
Dossiers and Marekting Authorisation Procedures:
- Dossier check (State of the Art)
- Compiling of eCTD/ NeeS for existing Dossiers
- Preparation CTD Dossiers
- Preparation Quality Overall Summary
- PIL Readability Test
- Country specific dossier compilation
- Application and filing of DCP / MRP / National procedure / Repeat-use / Renewal – Procedure/ International
- Management of deficiency letter and answering up to day 210 / day 90
- Execution of national phase after day 210 / day 90
- Expansion of Marketing Authorisations – Doublet Mas / DCP / MRP
- API-Dossiers, Application for CEP, Renewal-Procedures, Variations
Variations
- Per Marketing Autorisation/ Procedure Typ IA / Proceduremanagement per county
- Per Marketing Autorisation/ Procedure Typ IB / Proceduremanagement per country
- Per Marketing Autorisation/ Procedure Typ II / Proceduremanagement per county
- Management of deficiency letters
Monitoring activities
- Monitoring of Ongoing – Stabilities and administration of stability data
- „Sunset-Clause“ monitoring
- Monthly status report for all activities
- Dossier conformity - „Change Contol“
Use of Pharma Resources Name for Marketing Authorisation applications
- Application of a Marketing Authorisation under the name of Pharma Resources GmbH as Applicant
Holding of Marketing Authorisations as Marketing Authorisation Holder by Pharma Resources
- Holding of Marketing Authorisations as MAH (PR acts as pharmaceutical entrepreneur) by order of
