Regulatory Services

pharma, medical devices, food supplements, OTC, cosmetics

Comprehensive Regulatory Services

Regulatory Affairs  Strategy

  • Regulatory Support (CTA, import/export permits, GMP  auditing, etc.)
  • Labeling
  • Translations of Technical Documents
  • Coordination of Regulatory Certificates
  • Assessment of the Appropriateness of the Existing Documentation for an Approval in the Target Countries
  • Regulatory Strategy Development

Regulatory Requirements & Dossier Preparation

  • Clinical Trial Applications 
  • Marketing Authorisation Applications
  • Variations
  • Renewals
  • Legal Status change

Registration Procedure/Regulatory Management

  • National Applications
  • Regulatory support during the assessment
  • Appeals
Liaison with National Regulatory Authorities

Non-commercial Local Marketing Authorization Holder

Regulatory Development & Maintenance of Marketed Products

  • Changes to CMC (Chemistry, Manufacturing, Control)
  • Labeling Updates and Harmonization of Labels
  • Product Transfers
  • Company Mergers
  • Coordination of Regulatory Certificates
  • Special Projects

regulatory affairs, regulatory services

Categories of Healthcare Products

  • Pharma Drugs (New Chemical Entities & Generics)
  • Medical Devices
  • Herbals & Food supplements/Health supplements
  • Cosmetics and Nutricosmetics/Nutraceuticals
  • Over-the-counter (OTC) products
  • Biologicals, Biotech & Biosimilars

Contact us to know more about our wide range of Regulatory Services.