Regulatory Affairs

A multi-disciplinary and multi-lingual team of 25 Regulatory Affairs experts are at your disposal for all regulatory aspects of your Marketing Authorization Applications for Human and Veterinary Medicinal Products. Our SGS experts can explore the shortest route and timeframe to get your products in the market with European Regulatory Agencies.

Regulatory Affairs Expertise:

• Full regulatory support services from pre-clinical to post-marketing
• Experience in numerous product types:
  • Classical drugs
  • Herbal products
  • Recombinant-DNA
  • Oligonucleotide products
  • Vaccines
  • Blood Derivatives
  • Cell & Gene therapy
• Regulatory monitoring of the IMP (investigational medicinal product) development plan, including the set-up of Good Research Practice
• Overall guidance and consulting for setting up the EU regulatory strategy
• Gap analysis of US BLA’s for compliance with EU requirements
• Comprehensive country specific submission guideline