Regulatory coordination
Liaison, tracking and documentation for authorisation-related activities.
MAH Services
A dedicated regulatory contact for product registration and lifecycle requirements.
Marketing Authorisation Holder (MAH) services
Bpharma can discuss MAH-related service arrangements on behalf of companies, according to the product, jurisdiction, legal responsibilities and agreed scope.
Local requirements
Advice on applicable procedural and documentary expectations.
Lifecycle perspective
Continuity from initial application through subsequent changes.
Any formal MAH responsibility is subject to relevant authorisation, contracting and local law.