Putting together a drug dossier

Compliance with market authorization formalities and deadlines affects the successful product launch, the sales plans, and other product related KPIs.

Aston Health provides thorough support in bringing the product to market and expanding sales:

  • Preparing a complete drug dossier
  • Preparing application for new therapeutic indications
  • Providing rationale for product inclusion in the regional drug reimbursement programs
  • Putting together a drug dossier for inclusion in the restrictive lists
  • Certification of drug manufacturers to GMP standards

A dossier prior to inspection of production site should include the following:

  1. Application for conformity of the drug manufacturer with GMP requirements
  2. Information on identified deficiencies in the product quality
  3. List of products manufactured at the production site subject to inspection
  4. Letter of consent for conduct of an inspection
  5. GMP site file

The company's experts will provide you with support in management of issues related to GMP inspection

Aleksandr Ivanov

Aleksandr Ivanov

Head of Strategic Consulting Department