At Pharmaceutical Innovation Services S.L., we understand the critical role that the Marketing Authorization Holder (MAH) plays in the pharmaceutical industry. The MAH is a Company or legal entity that holds the authorization to market a medicinal product within one or more European Union (EU) Member States. As the MAH, this entity bears the ultimate responsibility for ensuring that the product complies with all regulatory standards set forth in EU legislation and guidelines. This responsibility extends to every aspect of the product’s lifecycle, from initial registration to post-market surveillance.

Expertise in Registration Procedures

One of the key responsibilities of the MAH is managing the registration process for medicinal products. This process varies depending on the type of procedure chosen, whether it be a national procedure, decentralized procedure (DCP), or mutual recognition procedure (MRP). Our team at Pharmaceutical Innovation Services S.L.  has experience in these procedures and can guide you through each step with confidence.

• National Procedure: For products intended to be marketed in a single EU Member State, we manage the entire national registration process, ensuring that your product meets all local regulatory requirements.
• Decentralized Procedure (DCP): If you wish to market your product in multiple EU Member States simultaneously, we can assist with the decentralized procedure, which allows for a streamlined registration process across several countries.
• Mutual Recognition Procedure (MRP): For products already authorized in one EU Member State, we can help extend the authorization to additional Member States using the mutual recognition procedure.

Our goal is to make the registration process as smooth and efficient as possible, minimizing delays and ensuring that your products reach the market quickly and in full compliance with all regulatory standards.

Representation and Commercial Transactions

In addition to managing registration procedures, Pharmaceutical Innovation Services S.L. can also represent your Company in various commercial transactions related to marketing authorizations. This includes the confidential sale or purchase of marketing authorizations (MAs) for individual medicinal products, as well as the transfer of product dossiers. Our expertise in this area ensures that these transactions are handled with the utmost confidentiality and professionalism, protecting your interests at every stage.

When you choose us as your MAH, you can also rely on us to represent your company under our name in any situation where it is necessary. This includes handling communications with regulatory authorities, managing Pharmacovigilance activities, and ensuring ongoing compliance with EU regulations. By acting as your MAH, we provide you with the peace of mind that your products are being managed by experts who are dedicated to maintaining the highest standards of quality and compliance.

Why Choose Pharmaceutical Innovation Services S.L.?

With years of experience in the pharmaceutical industry, Pharmaceutical Innovation Services S.L. is your trusted partner for all MAH-related needs. We understand the complexities of EU regulations and have the expertise to navigate them effectively on your behalf. Our comprehensive MAH services are designed to provide you with the support you need to bring your products to market and maintain compliance throughout their lifecycle.

Why choose Pharmaceutical Innovation Services S.L. as your partner for Marketing Authorization Holder (MAH) services?

The role of the Marketing Authorization Holder (MAH) is crucial in the pharmaceutical industry, carrying significant responsibilities that require expertise and diligence. At Pharmaceutical Innovation Services S.L., we offer MAH services, from managing registration procedures to representing your company in commercial transactions and ensuring ongoing compliance with EU regulations. Let us be your partner in navigating the complexities of the EU regulatory environment, so you can focus on what you do best—developing and delivering high-quality medicinal products to the market.