REGULATORY AFFAIRS

Human medicines

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Human medicines

We have expertise in various human medicines types: innovative, generics, non-prescription (OTC), herbal, biosimilars, biological, orphan, paediatric, advanced therapy (ATMP).

WE OFFER YOU

  • Cost effective regulatory strategies to gain competitive advantage

For new products development

For existing registered products (re-development, re-registration, etc.)

  • Project management
  • Compliance check/due diligence, updating and reformatting of files
  • Choosing the most appropriate type of procedure
  • Handling all type of registration procedures for various products in eCTD
  • Consultation on legal basis and classification of products
  • Handling registration procedures in all EU Member States
  • Preparation of Modules 1-5
  • Life cycle management
  • Regulatory requirements, strategies and the knowledge of the global product dossier
  • CMC documentation preparation (API and FDF)
  • EDQM – obtaining CEP
  • Environmental risk assessment (ERA)
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OUR SERVICES - WE FORSEE AND ADAPT