Global Managed Access Programme Supply Partner
GNH India provides regulated, compliant pharmaceutical supply in support of global managed access programs — enabling healthcare institutions, pharmaceutical companies, clinical teams, and government health bodies to access investigational, pre-approval, and unapproved medicines for patients with serious or life-threatening conditions across international markets.
As a WHO-GSDP certified pharmaceutical supplier based in Mumbai, India with over 22 years of global supply experience, we support managed access programme requirements through compliant sourcing, regulatory documentation management, and GDP-certified cold chain logistics — aligned with FDA, EMA, MHRA, and equivalent national regulatory authority frameworks worldwide.
Our managed access program supply services are structured exclusively for licensed healthcare institutions, pharmaceutical companies, clinical research organisations, and authorised medical practitioners — not for retail or direct-to-consumer pharmaceutical sales.
What Is a Managed Access Program?
A managed access program (MAP) is an overarching regulatory framework used by the pharmaceutical industry and health authorities to describe all forms of structured pre-approval access to investigational and unapproved medicines for patients with serious, debilitating, or life-threatening conditions — outside of the formal clinical trial setting.
Terminology for describing pre-approval mechanisms or programs may vary by country or even by drug manufacturer. They include Managed Access Program (MAP), Expanded Access Program (EAP), Named Patient Supply (NPS), Compassionate Use Program (CUP), and many others.
Managed access programmes typically apply when:
- A medicine is not yet approved or commercially available in the patient's country
- A medicine is approved elsewhere but not in the patient's country of residence
- A clinical trial has concluded but the patient still requires the investigational medicine
- Standard approved treatment options have been exhausted or are clinically unsuitable
- The patient has a serious, rare, or life-threatening condition with an unmet medical need
Our Scope & Capabilities
- Pharmaceutical supply in support of global managed access programmes
- Supply aligned with FDA Expanded Access, EMA Compassionate Use, MHRA Named Patient Supply, and equivalent national frameworks
- WHO-GSDP Certified Storage & Distribution
- ISO 9001:2015 Certified Quality Management System
- Licensed Pharmaceutical Supplier — State FDA Maharashtra
- IEC Licence for Global Pharmaceutical Export
- Regulatory Documentation & Compliance Support
- Temperature-Controlled Warehousing & Validated Cold Chain Logistics
- Specialist Supply of Orphan Drugs, Rare Disease, Oncology & Specialty Medicines
- Pharmacovigilance Coordination & Batch Traceability Support
How It Works — Our Managed Access Programme Supply Process
Programme Assessment & Regulatory Feasibility Review
We assess the managed access program requirement against applicable national and international regulatory frameworks — including FDA Expanded Access, EMA Article 83, MHRA Named Patient Supply, and equivalent country-specific pathways — to confirm regulatory feasibility, import authorisation requirements, and documentation obligations before any supply commitment is made.
Verified Sourcing & Quality Assurance
All medicines supplied under managed access programmes are sourced exclusively from WHO-GMP certified manufacturers and authorised supply channels — ensuring full product authenticity, batch-level traceability, and regulatory documentation integrity prior to dispatch. GNH India does not supply from unverified or unauthorised sources under any circumstances.
Regulatory Documentation & Programme Compliance Management
We assist healthcare institutions, pharmaceutical companies, and clinical teams with the preparation and organisation of required managed access programme documentation, including manufacturer certificates of analysis, import/export licensing records, country-specific regulatory authority application support documents, GDP-compliant shipping records, and pharmacovigilance coordination.
WHO-GSDP Compliant Warehousing & Cold Chain Handling
All medicines are stored and handled in validated, temperature-controlled facilities with continuous monitoring — maintaining full product integrity for biologics, injectables, oncology medicines, rare disease therapies, and all temperature-sensitive managed access medicines throughout their supply journey.
Global Compliant Delivery & Ongoing Pharmacovigilance Support
Our global logistics network supports GDP-compliant, traceable delivery directly to authorised healthcare institutions, hospital pharmacies, and clinical programme coordinators — with complete shipment documentation, real-time tracking visibility, and ongoing pharmacovigilance coordination for continuation or repeat supply requirements.
Why Choose GNH India for Managed Access Programme Supply?
GNH India Pharmaceuticals Limited has over 22 years of experience as a regulated pharmaceutical supplier supporting complex international supply programmes — including compassionate use, expanded access, named patient supply, and managed access frameworks across 180+ countries.
As a dedicated managed access program supply partner, we combine regulatory expertise, quality-assured global sourcing, and GDP-compliant logistics to ensure uninterrupted access to critical pre-approval and unapproved medicines for patients who need them most.
- WHO-GSDP Certified Pharmaceutical Supply
- ISO 9001:2015 Certified Quality Management System
- Licensed by State FDA Maharashtra
- IEC Authorised Pharmaceutical Exporter
- Member — Pharmaexcil (Pharmaceuticals Export Promotion Council of India)
- Member — FIEO (Federation of Indian Export Organisations)
- 22+ Years of Global Pharmaceutical Supply Experience
- Supply Aligned with FDA, EMA, MHRA, TGA & 180+ Country Regulatory Frameworks
- Dedicated Regulatory Documentation & Compliance Support Team
- End-to-End Cold Chain & Temperature-Controlled Logistics
We operate strictly as a regulated B2B and institutional pharmaceutical supply partner. We do not engage in retail or direct-to-consumer medicine sales.
Regulatory & Compliance Information
GNH India operates under the following compliance frameworks relevant to managed access programme supply:
Global Managed Access Regulatory Frameworks Supported
Individual patient, intermediate-size population, and treatment IND pathways for managed access to investigational medicines. Requirements include IND authorisation, IRB approval, and FDA notification or prior approval depending on access type.
Cohort-level managed access for medicinal products undergoing clinical trials or marketing authorisation review. Applicable across all EU member states.
Individual patient named patient basis supply of unlicensed medicines under Human Medicines Regulations 2012, Regulation 167.
Category A, B, and C managed access pathways for unapproved therapeutic goods.
Form 12A and special import provisions for managed access to unapproved medicines.
Including ANSM Accès Précoce (France), BfArM §21a AMG Compassionate Use (Germany), AIFA Uso Compassionevole (Italy), SWISSMEDIC (Switzerland), SAHPRA Section 21 (South Africa), ANVISA Expanded Access (Brazil), and equivalent national authority pathways across 180+ countries.
Regulatory Recognitions
Quality You Can Trust
Our internationally recognised certifications underscore our commitment to safety, quality, and excellence in managed access programme pharmaceutical supply.
