Before committing resources to a clinical program or product launch in India, you need clarity. What regulatory pathway applies? What does CDSCO require? How long will it take? What are the risks? Zetalix's Regulatory Assessment provides a structured, expert evaluation delivering a clear, actionable roadmap within 10 business days.
What's Included
Phase 1: Product & Program Review
- Review of product dossier (CMC, nonclinical, clinical data to date)
- Evaluation of therapeutic indication and target population
- Assessment of prior regulatory submissions (FDA, EMA, TGA, PMDA) and relevance to India
- Product classification under Indian regulations (New Drug, Generic, Biosimilar, Nutraceutical, Device, AYUSH)
Phase 2: Regulatory Pathway Mapping
- Correct regulatory pathway identification (CDSCO CTA, FSSAI, AYUSH licensing, medical device notification)
- Pathway comparison (full vs. abbreviated vs. waiver-eligible)
- Global clinical data acceptability assessment
- Bridging study evaluation based on ICH E5 ethnic sensitivity factors
Phase 3: Gap Analysis
- Detailed gap analysis: existing dossier vs. Indian regulatory requirements
- Missing data, studies, or documentation identification
- CMC/quality gap assessment against Indian pharmacopoeial standards
- Stability data evaluation (ICH Zone IV — 40°C/75% RH)
Phase 4: Timeline & Cost Estimation
- Realistic timeline projection from submission to approval
- Phase-wise cost estimation: regulatory fees, study costs, site costs, operational expenses
- Critical path activities and timeline risk identification
Phase 5: Risk Assessment & Mitigation
- Regulatory, scientific, and operational risk identification
- Mitigation strategies per risk
- Go/no-go recommendation with supporting rationale
Phase 6: Deliverable — Regulatory Assessment Report A comprehensive written report (15–25 pages):
- Executive summary
- Product classification and pathway recommendation
- Gap analysis findings
- Timeline and cost projections
- Risk assessment matrix
- Recommended next steps
- Appendix with relevant CDSCO guidelines
Who Should Request a Regulatory Assessment?
- International pharma companies evaluating India for clinical trials
- Generic drug manufacturers seeking BA/BE and ANDA-equivalent approval in India
- Nutraceutical companies planning Indian market entry
- Biotech companies with biosimilars, biologics, or cell/gene therapy products
- Medical device companies navigating India's evolving device regulations
- Academic institutions planning investigator-initiated research in India
- Investors and due diligence teams assessing regulatory risk for Indian clinical assets