Licensing, Dossier and Accreditation
Our regulatory affairs team prepares submission ready dossiers and guides you through licensing and GMP certification with confidence.
Licensing, Dossier and Accreditation by Zanax Health
Regulatory approval is the gateway to every market. Incomplete dossiers, missing data or poorly prepared audits can stall product launches for a year or more.
Zanax Health provides end to end regulatory support. We compile CTD, ACTD and country specific dossiers, manage licence applications with Indian authorities and prepare facilities for WHO-GMP, EU-GMP and PIC/S inspections.
What We Deliver
CTD and ACTD Dossiers
Complete Module 1 to 5 compilation for regulated and ROW markets.
eCTD Publishing
Validated eCTD sequences ready for electronic submission.
Product Registration
Country specific registration support and query management.
Drug and Manufacturing Licences
Applications with CDSCO and State FDA, including export NOCs.
GMP Accreditation
WHO-GMP, EU-GMP and PIC/S readiness and certification support.
Gap Analysis and CAPA
Mock audits, gap reports and corrective action planning.
Our Process
Assessment
Review of existing data, documents and target market requirements.
Compilation
Dossier writing, data generation plan and document collation.
Submission
Filing with the authority and tracking of review timelines.
Query Response
Deficiency responses and support until approval.
Why Clients Choose Us
- Experienced regulatory affairs professionals
- Country specific dossier templates and checklists
- Faster approvals through first time right submissions
- Lifecycle support for renewals and variations
- Audit preparation led by former QA heads
Frequently Asked Questions
What is the difference between CTD and ACTD?
CTD is the ICH format used by most regulated markets, while ACTD is the ASEAN variant with its own structure for quality, safety and efficacy sections. We prepare both.
Do you support WHO-GMP certification?
Yes. We carry out gap assessments, prepare documentation and SOPs, train teams and support the site during inspection.
Can you manage renewals and variations?
Yes. We handle post approval variations, renewals and periodic updates so your registrations remain valid.
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Explore ServiceReady to Discuss Your Licensing, Dossier and Accreditation Requirement?
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