REGULATORY AFFAIRS - Regulatop

Go to content

Main menu

REGULATORY AFFAIRS

Regulatory support is provided on Drug Products (Human and Veterinary) and Medical Devices

  • MA Submission Strategy in complex scenarios

  • Feasibility Studies

  • Start-up of a pharma company (Italy)

  • Due Diligence on companies/portfolio acquisition

  • MA Submissions, Variations and Renewals

  • Full CMC expertise, Human and Vet, EU and USA

  • Technical Writing (Translations IT-EN, Expert's Overviews, SmPC and PIL drafting, Health Manual, SOPs)

  • Medical Devices: from feasibility analysis to CE marking

  • GMP related regulatory tasks (manufacturing plants)

  • Regulatory Training (tailored, on-site)

  • Support in optimization of Regulatory Departments performance



 
 
Back to content | Back to main menu