Regulatory Affairs Compliance

Due to its high expertise in the regulatory affairs field, Telstar provides full support for clients throughout the lifecycle of products, advising and keeping dossiers up to date.

 Active ingredients

  • DMF guidance / preparation / variation (EU / USA)
  • Guidance, strategy, variation and support documentation to obtain CEP (EDQM)

Medicinal products

  • Registration strategy and dossier submissions in Europe and to the FDA
  • Dossier writing and compilation
  • Variations, revalidation, e-cTD formatting
  • eXtended Medicinal Product Dictionary (XEVMPD). Article 57(2). Compliant laboratories and products registration processes
  • Laboratory authorization processes guidance
  • Due diligence of dossiers

Telstar Value Services

We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success.

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Related Products and Services

Third Party Quality Audits

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QA Services

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Data Integrity

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