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 as products within the European Union (EU) Member States. This entity holds ultimate responsibility for guaranteeing the product complies with all regulatory and quality standards outlined in EU legislation and guidelines.This responsibility extends to every aspect of the product’s lifecycle, from initial registration to post-market follow-up.

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 (NP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP) or Centralized Procedure (CP). 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.
• Centralized Procedure (CP): for products intended for marketing across the EU, we manage the entire centralized authorization process, ensuring your product meets European regulatory requirements.

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 in 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 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, ensure product quality, 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. as your partner for Marketing Authorization Holder (MAH) services?

With extensive experience in the pharmaceutical industry, we are your trusted partner for all MAH-related needs. We handle registration, compliance, and commercial representation, ensuring your products meet EU regulations throughout their lifecycle. Let us navigate these complexities so you can focus on what you do best— delivering safe, high-quality medicines.