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.
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.
