- Regulatory strategy
- Compilation of dossier texts
- Regulatory Affairs Chemistry Manufacturing and Controls (RA-CMC), including creation of Common Technical Document (CTD) modules 2 and 3.
- Regulatory Submissions
- Clinical Trial Applications
- Scientific Advice Support
- Summary of Product Characteristics (SmPC)
- Interim management
- RA support during development and after regulatory approval of NCEs
- RA support during development or after regulatory approval of generics
- RA maintenance activities including: creation and submission of variations, renewals, and line extensions
- Regulatory Compliance, including the related processes.
- Management of EU Regulatory procedures: National Procedures, Mutual Recognition Procedures (MRP), Decentralized Procedures (DP) and Centralized Procedures
- USA regulatory activities in cooperation with Garden State Pharmatech
- Liaison with health authorities
SonsbeekPC has access to a broad network of RA experts within and outside the EU. These experts will be involved in case of country/ region / specific requests or requests for which other specific expertise is required.