Services

Pharmaceuticals / Biologicals / Biosimilars / Medical Devices / Diagnostics / Cosmetics

  • Full Regulatory Service
  • Regulatory Agent
  • Strategic Health
  • Technology Agent
  • Operational
  • Secure Central Repository
  • Services for CMC
  • e-Publishing

Hand-picked Regulatory Affairs specialists with a wealth of hands-on regulatory experience particularly at the strategic and tactical level provide:

  • Strategic/ operational drug development planning
  • Scientific advice, including dossier preparation, strategic planning and management of authority meetings 
  • Regulatory authority negotiations during development
  • OTC switches and extensions of existing OTC products in Europe and Asia
  • e CTD and dossier creation, including publishing 
  • Regulatory writing, overviews and summaries 
  • Broad geographical reach 
  • Senior Health Authority people knowledge, in particular China, South Korea, Japan, India, Russia, Brazil, Mexico, Asia, Pacific, Middle East, North America and Europe
  • Information management
  • CRO China and Japan
  • Due diligence

We have alliances with other specialist scientific companies to extend our Client service.

Regulatory Agent (click)

Services for Chemistry Manufacturing and Quality Controls (click)

Health Technology Assessments (click)