Regulatory Affairs
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Regulatory Affairs

Regulatory Affairs

We provide a wide range of services related to pre- and post-submission issues in pace with product lifecycle

 

  • Regulatory strategy advice and execution
  • Regulatory submissions under DCP/MRP¹ and pure NP²
  • Post-marketing applications and MA³ maintenance support
  • Linguistic support for product information of CAPs⁴
  • Regulatory intelligence
  • Regulatory documentation assessment and upgrade
  • Compilation of quality, non-clinical and clinical overviews and summaries
  • Readability testing of package leaflets
  • Consultancy on promo and educational materials
1. Decentralized / Mutual recognition procedures (DCP/MRP); 2. National Procedure (NP); 3. Marketing Authorisation (MA); 4. Centrally Authorized Products (CAPs)

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