A dedicated MAH strategy ensures successful product registration, commercialization, and long-term regulatory compliance in each country or region where the medicine is marketed.
Our service offering can be structured into the following strategic pillars:
Global MAH Landscape Assessment
A structured approach to identify qualified MAH options in each region.
Key Service Components
Mapping of regulatory frameworks:
- EU (MAH must be based in EU/EEA)
- UK, GCC, ASEAN, LATAM, Africa, US (NDA/ANDA holders), etc.
Identification of:
- Local MAH service providers
- Regional pharmaceutical companies
- License partners and distributors
- Contract MAH organizations
Country-specific MAH requirements:
- Legal presence
- PV system requirements
- QPPV / LRP requirements
- Serialization & compliance obligations
MAH Suitability Evaluation Framework
A due-diligence model to evaluate potential MAHs based on business, compliance, and operational capabilities.
Evaluation Criteria (High-Level)
- Regulatory track record
- Inspection / audit history
- Experience with therapeutic area or formulation
- Local distribution network strength
- PV and safety reporting infrastructure
- Quality management maturity
- Financial stability
- Ability to support labeling, variations, renewals
Deliverables
- MAH scorecards
- Weighted evaluation matrix
- Shortlisting of best-fit MAHs per region
Global MAH Partner Identification & Outreach
A structured service for initiating contact and securing interest.
Activities (Business-Focused)
- Pre-screening of MAH organizations
- Initial business discussions
- NDA (non-disclosure agreement) coordination
- Sharing of high-level product information packages
- Negotiation support for roles & responsibilities
Regulatory & Compliance Alignment Support
Ensures the chosen MAH can fully meet regulatory expectations.
MAH Capability Support Areas
- Local regulatory requirements review
- Gap analysis for pharmacovigilance compliance
- Assessment of MAH responsibilities for:
- Labeling
- Artwork approval
- Post-approval variations
- Renewals
- Safety updates
- Serialization / track & trace compliance
- Mapping MAH obligations vs. manufacturer obligations
MAH Contracting & Governance Support
Ensures strong collaboration and clear responsibilities.
Contractual Support Includes
- Defining responsibilities matrix (RACI)
- Quality / regulatory responsibility agreements
- Pharmacovigilance agreement review
- Recall and complaint handling roles
- Data sharing and documentation obligations
- Market access & distribution alignment
Post-Selection Implementation Services
Support for onboarding the MAH after selection.
Implementation Support
- Transfer of regulatory dossiers
- Conduct of local regulatory submissions through MAH
- Change management support for variations
- Establishment of local PV system
- Training of MAH teams on product-specific requirements
- Compliance monitoring (KPIs, audits, periodic review)
Regional Strategies for MAH Selection
Different regions require tailored solutions.
Europe (EU/EEA)
- MAH must legally reside in the EU.
- Often outsourced to specialized MAH service providers.
Middle East / GCC
- MAH roles often linked with local agent/distributor.
- Strong local presence required.
Africa
- Many regions require locally registered MAH entities.
- Partnerships with local pharmaceutical companies common.
Asia (India, ASEAN, China)
- MAH may require local technical staff and PV infrastructure.
- Multiple regional partners may be needed.
Latin America
- Local representation is mandatory in many countries.
- MAH often tied to local distributor agreements.
United States
- MAH equivalent: NDA/ANDA Holder.
- Can be the sponsor company or a US-based affiliate.
Risk & Compliance Management
Maintain long-term security and regulatory continuity.
Risk Control Services
- Risk assessment for MAH continuity
- Backup MAH identification
- Compliance monitoring program
- Business continuity and supply chain alignment
