Regulatory Affairs

Stark Associates provides strategic consulting for various processes of the life sciences regulatory domain and we support leading life science companies in the development of high-quality regulatory documents for Europe, US, Middle East, Africa and other emerging markets with a strong regulatory team experienced in scientific research and clinical practice.

Regulatory Affairs
  • Clinical Trial Application Dossiers
  • Compile Dossiers for New Product Launch
  • CMC Change Controls and Variations
  • Investigator Brochures (IB), Informed Consent Forms
  • Clinical Study Synopsis, Protocols and Amendments
  • Clinical Study Reports (CSRs); Phases I to IV and BA/BE
  • Clinical Trial Registries and Results Disclosure
  • Drug Master File (DMF) & Investigational Medicinal Product Dossier (IMPD)
  • SAE reports for Health Authorities and IRBs Submission
  • Company Core Data Sheet (CCDS)
  • Summary of Product Characteristics (SmPC)
Regulatory Publishing
  • Publishing Services (eCTD, NeeS, Paper)
  • SPL Submission Services
  • Artwork Services
  • Product Lifecycle Management
Artwork Labelling
  • Design of art-work labels
  • Local Product Labels
  • Patient Leaflets, Inner and Outer Package Labels
  • Product Information File (PIF), SPL creation
Regulatory Intelligence
  • Regulatory Strategic Planning for New Product Development and Launch
  • New Market Regulatory Strategy Intelligence
  • Specialized Strategic Planning for Fast Tracked and Orphan Products
  • Access, Summarize and Assess Global Regulatory Intelligence
Medical Device Submissions
  • PMA, 510 (k) and HDE submissions
  • Implementation of Unique Device Identification (UDI)