Our Services

Advisory Services

Regulatory Services

Regulatory Intelligence
  • Regulatory intelligence - real-time access to current requirements
  • Optimized time to key decision points
  • Market research, competitor's product review, Regulatory Database review
  • Specialty designations in areas such as orphan disease, regenerative medicine, advanced and breakthrough therapies, pediatrics, adaptive pathways, and more
Technical / Scientific Due diligence
  • Gap Analysis and Due Diligence
  • Scientific review of claim substantiation
  • Claim assessment/Label review
  • Regulatory and operational risk mitigation
  • Flexible approaches to generating more informative evidence earlier
Regulatory Roadmap & Strategy
  • Innovative & Compelling Regulatory Roadmaps
  • Streamlined regulatory submission pathways
  • Regulatory Program Strategy
  • Competitive analysis
  • Advising on legal basis and product classification
Registration & Marketing Authorisations
  • Submission ready Dossier preparation (M1-5)
  • Support for Marketing Authorization applications submissions locally
  • Publishing of Dossier CTD, eCTD, Nees, Paper and customized dossiers- working with Partners
Lifecycle Management
  • Line extensions, Variation dossier writing, labeling updates, marketing authorization transfers, CMC changes
  • Submission-ready document preparation
  • Technical formatting
  • Rx to OTC
  • New claim /New Indication/New strength/line extension
  • Labelling updates –SPC/PIL

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