Accelerating global
pharmaceutical
market access.
Astan Medicorp guides pharmaceutical manufacturers through CTD/eCTD dossier preparation, product registration, GMP compliance and international market entry — from our regulatory desk in India to authorities across six continents.
A regulatory desk built by people who have sat on the other side of the review table.
Astan Medicorp Pvt. Ltd. is an international pharmaceutical regulatory affairs and market access consultancy headquartered in India. Our team works exclusively at the intersection of science, documentation and policy — preparing the dossiers, technical files and compliance records that determine whether a product reaches patients.
We work as an extension of our clients' regulatory teams: precise in submission strategy, disciplined in documentation, and direct in communication. Every engagement is treated as confidential and every deadline as fixed.
"To simplify global pharmaceutical registration through scientific excellence, regulatory expertise, and strategic guidance."
"To become one of the world's most trusted pharmaceutical regulatory consulting and market access organisations."
Experienced regulatory professionals, expertise across multiple submission formats, and solutions shaped around each client's product portfolio rather than a fixed template.
Confidentiality and quality are treated as non-negotiable — documentation is version-controlled, reviewed, and submission-ready before it leaves our desk.
Integrity
Scientific Excellence
Regulatory Compliance
Innovation
Client Partnership
Global Quality Standards
Six disciplines, one regulatory desk.
From first regulatory strategy conversation to post-approval lifecycle management, every service is delivered by specialists who work in that discipline daily.
Regulatory Affairs
- CTD, ACTD & eCTD dossier preparation
- Product registration
- Regulatory strategy & gap analysis
- Lifecycle management
Global Registrations
- ASEAN & GCC markets
- Africa & LATAM
- CIS & European Union
Quality & Compliance
- GMP documentation
- SOP development
- Validation documentation
- Audit readiness
Artwork & Packaging
- Label & carton artwork
- Leaflets & mock-ups
- Packaging compliance review
Pharmacovigilance
- PSMF documentation
- Safety reporting support
- PV system consulting
International Business Support
- Pharma export consulting
- Third-party manufacturing
- Product sourcing & licensing
Registration pathways across six regions.
Each market has its own dossier format, submission portal and review timeline. We track all six, so your team only has to manage one relationship.
ASEAN
SE ASIAGCC
GULFAfrica
AU / ZAZIBONALATAM
LATIN AMERICACIS
EURASIAEurope
EU / UKFrom first consultation to ongoing support.
Consultation
We review your product, target markets and current documentation to understand the registration challenge.
Planning
A regulatory strategy and timeline is built against each target authority's requirements.
Documentation
Dossier modules and technical files are drafted to CTD, ACTD or eCTD standard.
Review
Internal quality review checks completeness and regulatory accuracy before submission.
Submission
Dossiers are filed through the relevant national or regional portal, fully tracked.
Approval
We manage query responses and authority correspondence through to approval.
Ongoing Support
Post-approval lifecycle management, variations and renewals keep you compliant.
Built for regulatory teams that can't afford delay.
International Regulatory Expertise
Submission experience spanning multiple regional and national authorities.
Scientific & Technical Excellence
Dossiers written by people fluent in the underlying science, not just the format.
Fast Turnaround
Defined timelines for every deliverable, tracked from kickoff to submission.
Confidential Handling
Product and portfolio information is handled under strict confidentiality throughout.
Cost-Effective Solutions
Scoped engagements that match the size and stage of your registration need.
Dedicated Project Management
A single point of contact coordinates every workstream and authority query.
Working across the pharmaceutical supply chain.
Ready to take your product into a new market?
Tell us about your product and target geography — we'll respond with a regulatory pathway and timeline.