A Marketing Authorization Holder (MAH) is the legal entity responsible for obtaining and maintaining the authorization to market a medicinal product across Europe. The MAH ensures compliance with EU/UK regulations, including Good Manufacturing Practices (GMP), pharmacovigilance obligations, supply chain oversight, and quality control. The responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH. For pharmaceutical companies without an EU or UK presence, securing an experienced MAH partner is critical to regulatory success.
With over 20 years of experience in commercializing medicinal products, ProPharma has successfully supported pharmaceutical companies worldwide in achieving marketing authorization, achieving reimbursement, and maintaining compliance. We provide:
Partner with ProPharma to simplify your market entry across Europe and ensure long-term compliance. Contact us today to learn more about how we can support your marketing authorization needs.
Navigating both the specific country and centralized European regulations and requirements to supply medicinal products to the European markets can be a complex challenge.
With decades of experience, our experts provide a full spectrum of MAH services to support pharmaceutical companies in successfully navigating the regulatory requirements across Europe. Our tailored solutions ensure compliance, streamline market entry, and maintain product integrity.
Pharmaceutical companies—whether generic or biosimilar manufacturers, orphan drug or ATMP (cell and gene) manufacturers, non-EU companies or innovative drug developers—face unique challenges in obtaining EU marketing authorization. We offer specialized solutions to address these hurdles.
ProPharma offers comprehensive support by guiding companies through regulatory pathways, conducting gap analyses, facilitating regulatory meetings, ensuring quality compliance, and providing QPPV services. With expertise in pricing strategies and logistics, ProPharma streamlines the EU market entry process for US companies, ensuring regulatory success and commercial viability.
ProPharma provides tailored solutions by offering expert guidance on bioequivalence studies, dossier compliance, and regulatory submissions, as well as comprehensive support for GMP implementation, QPPV services, and pricing strategies. By streamlining the authorization process, ProPharma enables generic and biosimilar development companies to efficiently enter and succeed in the European market.
September 4, 2025
Discover strategies to enhance efficiency and quality in high-volume medical information contact centers, reducing call strain while improving customer satisfaction and agent performance.
September 3, 2025
Discover how our MAH expertise in Eastern Europe ensures seamless regulatory compliance, lifecycle management, and strategic market entry.
September 2, 2025
Reduce delays & risks: streamline your MLR submissions with ProPharma’s expert checklist. Prepare materials that minimize delays, reduce risks, and accelerate approvals.
July 8, 2025
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
September 3, 2025
Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...
August 21, 2025
Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...
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August 4, 2025
Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...
September 23, 2025
Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...
September 17, 2025
In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...
July 29, 2025
Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...
September 4, 2025
Discover strategies to enhance efficiency and quality in high-volume medical information contact centers, reducing call strain while improving customer satisfaction and agent performance.
September 3, 2025
Discover how our MAH expertise in Eastern Europe ensures seamless regulatory compliance, lifecycle management, and strategic market entry.
September 2, 2025
Reduce delays & risks: streamline your MLR submissions with ProPharma’s expert checklist. Prepare materials that minimize delays, reduce risks, and accelerate approvals.
July 8, 2025
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
September 3, 2025
Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...
August 21, 2025
Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...
August 4, 2025
Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...
September 23, 2025
Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...
September 17, 2025
In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...
July 29, 2025
Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...