Regulatory Affairs

A multi-disciplinary and multi-lingual team of Regulatory Affairs experts are available for all regulatory aspects of Marketing Authorization Applications for Human and Veterinary Medicinal Products. These services are a seamless part of the drug development process, from pre-clinical through post-marketing. SGS experts can explore the shortest route and timeframe to get products into the market with European Regulatory Agencies.

Regulatory Affairs services:

• Clinical trials regulatory support
  • Clinical Trials Applications (EU Directives and country specific applications, CTX)
  • Import License for CTS
  • Labeling for investigational products
  • Drug importation
• Marketing and Authorization Applications
  • Centralized procedure
  • National and Mutual Recognition procedures
  • European and national variations and renewals
  • Abridged applications
  • Updating of dossiers for EU enlargement
  • Liaison with European Regulatory Agencies (National and EMEA)
  • Review and assessment of technical and scientific data
  • Preparation of all CTD modules and converting of EU files into CTD format
  • Bibliographic and on line research
  • Ecotoxicological risk assessment
  • Pricing and Reimbursement
  • Regulatory Consultancy for Advertising, review of promotional materials by qualified people
• Labeling
  • EU Readability testing of patient information leaflets (PILs)
  • Translation of European SmPCs and PILs
  • Translation checking of European labeling by Pharmaceutical multilingual staff
  • SmPCs harmonisation
• Medical writing
  • Written and tabular summaries (CTD)
  • Investigator's Brochure
• MRL Dossiers
  • Specific consultancy for Veterinary Medicinal Products
• Medical Devices
  • Technical files for Medical Devices (all classes) conforming to the European directive
• Cosmetics, Food supplements and Nutriment Biocides
  • Preparation, submission and maintenance of dossiers according to national and EU legislation
• EU representation of non European companies
• On-site consulting
  • Qualified and multilingual staff

Contact our Regulatory Affairs Consultants for more information.