Regulatory Affairs

Regulatory Affairs Services

Jeevan supports 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.

“Jeevan with its vast expertise provides diversified solutions for all regulatory requirements
with a competitive edge and best practices”

Key Services:

  1.   Regulatory affairs

  2.   Regulatory Strategy and Intelligence

  3.   Regulatory Writing

  4.   Regulatory Business and Outsourcing Consultancy

  5.   Regulatory Operations

  6.   Regulatory Labelling

A. Regulatory affairs
  • Compile Dossiers for New Product Launch
  • Post Approval Changes, Gap Analysis and HA Responses
  • Bibliographic and Line Extension Applications
  • CMC Change Controls and Variations
  • Clinical Trial Application Dossiers
B. Regulatory Strategy and 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
C. Regulatory Writing
  • Clinical Study Synopsis, Protocols and Amendment
  • Investigator Brochures, Informed Consent Documents
  • Clinical Trial Registries and Results Disclosure
  • Drug Master File (DMF) & Investigational Medicinal Product Dossier (IMPD)
  • Safety and Patient Narrative Writing
  • SAE reports for Health Authorities and IRBs Submission
D. Regulatory Business and Outsourcing Consultancy
  • Regulatory Business Strategy Consultancy
  • Regulatory Compliance Consultancy
  • Regulatory Centralization
  • Regulatory Outsourcing Services
E. Regulatory Operations
  • Publishing Services (eCTD, NeeS, Paper)
  • SPL Submission Services
  • Artwork Services
  • Product Lifecycle Management
F. Regulatory Labelling
  • Company Core Data Sheet (CCDS)
  • Local Product Labels
  • Summary of Product Characteristics (SmPC)
  • Patient Leaflets, Inner and Outer Package Labels
  • Product Information File (PIF), SPL creation
  • Supporting Documentation (Clinical and Non-clinical overviews)