Program Services
Building an access program in India requires alignment between the manufacturer, treating teams, eligible patients and the supply chain. MitoGENE MAP™ helps pharmaceutical and biotechnology companies assess and coordinate these requirements through a program-specific operating model.
We work with partners to define responsibilities, documentation, supply arrangements and reporting before implementation. The scope is tailored to the product’s regulatory status, the intended patients and the applicable Indian pathway.
From Program Design to Local Coordination
End-to-end operational support to plan, enable and run Managed Access Programs in India.
Services
Program feasibility and
pathway assessment
Define the intended access model,
eligible population, product status and
operational requirements. Identify the
permissions and stakeholder responsibilities
relevant to the proposed program.
Physician and
hospital coordination
Support participating teams with
program information, referral workflows
and documentation requirements under
the sponsor’s approved procedures.
Patient-access
administration
Coordinate referral records and eligibility
documentation against program criteria.
Clinical decisions remain with treating
physicians; program eligibility decisions
follow the sponsor’s governance framework.
Supply and
inventory planning
Plan replenishment, product accountability,
expiry management and delivery
requirements with the manufacturer
and appointed supply partners.
Import and
distribution coordination
Coordinate the applicable import
documentation, customs interfaces and
product-specific transport arrangements,
including temperature controls where required.
Program reporting
and safety interfaces
Agree operational reports and escalation
procedures, including the timely transfer of
reported safety information to the designated
pharmacovigilance team.
Programs we can help assess
Early or pre-launch access initiatives, structured access for defined patient groups, and continuity arrangements where a suitable lawful pathway exists. Program terminology does not itself determine eligibility or regulatory permission; each proposal is assessed individually.
Early or
Pre-launch
Access Initiatives
Structured Access for Defined Patient Groups
Continuity
Arrangements
Data and EvidenceSupport Where Appropriate
Where included in the agreed scope, program data collection can be coordinated under a sponsor-approved plan with defined consent, privacy, ethics and data-quality requirements.
Operational reporting and scientific evidence generation serve different purposes; an access program does not automatically constitute an evidence-generation study.
How We Work With Your Team
A step-by-step, collaborative approach to design, implement and operate your access program in India.
- 1
Understand the Objective
Review the product, patient population, proposed access model and India requirements.
- 2
Define the Operating Plan
Agree responsibilities, documentation, supply arrangements and reporting.
- 3
Prepare for Implementation
Coordinate the required permissions, partner readiness and participating-site workflows.
- 4
Support Program Operations
Coordinate agreed referral, supply and reporting activities.
- 5
Review Continuity and Closure
Plan replenishment, patient-transition arrangements and product reconciliation with the sponsor.
Frequently Asked Questions
Quick answers to common questions about NPP, MAP and program participation.
How does MAP differ from NPP?
NPP addresses an individual patient’s prescribed medicine requirement. MAP supports a manufacturer-led program with defined eligibility criteria, operating procedures and responsibilities across participating patients or sites.
Are medicines always supplied free of charge?
No. Supply terms are determined by the manufacturer’s program and the applicable legal framework. They must be established before implementation.
Can any hospital participate?
Participation depends on the selected pathway and program criteria. Some routes have institution-specific restrictions; suitability must be confirmed for each participating site.
Plan yourIndia Access Program
Share the product’s regulatory status, intended population, proposed supply model and expected timeline. We will work with your team to assess a suitable operational scope.
Discuss a Program info@mitogene.orgProgram support is scoped individually and remains subject to applicable requirements,permissions and partner agreements. Critical sponsor and pharmacovigilance responsibilities remain with the designated accountable parties.