Regulatory Services
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Focused on addressing changing regulatory needs Era Pharma Solutions can support you with a complete range of regulatory services through expertise in regulatory consulting and guidance for local and international submissions.

  • Regulatory and Medical Services for Local and Regulated Market, Marketing Authorization and Dossier preparation for submission in the Turkey, Europe, US.
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In-licensing and out-licensing dossier audit and submission dossier preparation

 

 

  • Marketing Authorisation application for all Pharmaceutical Products, Biotechnology Products, Biological products and Blood products, OTC, Herbal drugs and medical devices.
  • All types of variation applications (Manufacturing site change variation from import product to local production, MA holder changes, renewal variations, etc.),
  • Expert reports
  • Follow-up and monitoring the registration period in related health authority, in accordance with the applicant’s demands
  • Regulatory team audit for finished product dossiers(Technical evaluation and adaptability to local regulation reports)
  • Nonclinical Reports
  • Medical support in preparation of medical parts of submission dossiers ( Literatures, Medical writing, Summary reports, etc.)
  • Pharmacovigilance Services.