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.
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ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
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ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
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ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
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Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...
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Discover how ProPharma enabled a leading global biopharma to overcome fragmented clinical sample management and outdated manual processes. Faced with disparate systems, off-site inventories, and...
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Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...
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