How Zetalix Navigates India's Regulatory Space

Zetalix has developed a structured, repeatable methodology for navigating India's regulatory environment — eliminating ambiguity, reducing timelines, and ensuring first-time-right submissions.

Step 1: Regulatory Intelligence & Landscape Analysis We map current regulatory requirements against your specific product, indication, and development stage — reviewing latest CDSCO notifications, gazette amendments, and precedent approvals.

Step 2: Pathway Determination & Strategy We determine the optimal pathway — full CTA for new molecular entities, abbreviated for biosimilars, ANDA-style for generics, or FSSAI for nutraceuticals — and present clear strategy with timelines, milestones, and risk factors.

Step 3: Pre-Submission Preparation Complete submission dossier in CDSCO CTD format — Module 1 (administrative), Module 2 (summaries), Module 3 (quality/CMC), Module 4 (nonclinical), Module 5 (clinical). Every document undergoes internal QC before submission.

Step 4: CDSCO Engagement & Submission Applications submitted via SUGAM portal with active CDSCO communication. For complex applications, we facilitate pre-submission meetings to align expectations proactively.

Step 5: Ethics Committee Coordination We manage EC submissions across all trial sites — preparing dossiers, attending EC meetings, and tracking approvals to prevent site activation delays.

Step 6: Query Management & Approval Tracking Centralized tracking system with defined response timelines. Regulatory team drafts query responses with sponsor's medical/scientific team for accuracy and alignment.

Step 7: Post-Approval Compliance Ongoing regulatory obligations — protocol amendments, safety reporting, annual progress reports, and regulatory inspection management throughout the trial lifecycle.

Step 8: Marketing Authorization Support Transition from CTA to NDA — managing marketing authorization submission, GMP inspection coordination, and labeling approval.