logoSPC

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.

email Jan-Jaap Scherpbier linkedin Ja-Jaap Scherpbier  Phone: (+) 26 4451871 Mobile Phone: (+) 31 614781447