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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
