Evaluation of drug product documentation under time pressure

  • Medium-sized EU-based pharmaceutical company.
  • The client intended to acquire the marketing authorizations for three strengths of an oral anti-diabetic medicinal product intended for use in patients with type II diabetes.
  • Client was in the need of due diligence to review the dossier and assess the quality of a planned acquisition by the company before imminent expiry (Sunset Clause).
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