Regulatory Affairs

• 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.