REGULATORY SERVICES - PHARAMACEUTICALS

We as a globally connected team of regulatory specialists support you as our customers in all aspects of regulatory affairs and provide your company with what is needed to succeed in the pharma industry

  • New product Authorisation-Finished products
  • New product Authorisation- APIs
  • Post approval-CMC & Life cycle management
  • Regulatory assessment / GAP Analysis
  • Regulatory consulting & Strategy
  • Health Authority Queries, Responses / Interactions
  • Market Authorisation Application (MAA)-Article 10(1)
  • MAA-Post Approval Submissions
  • MAA-License Renewal
  • Active Master File (ASMF) submissions
  • Certification of suitability (CEP) submissions
  • Sister CEP submissions
  • Dossier Templates for USFDA & EU Regulatory Submissions