Proregulations' Comprehensive EU MAA Solutions

Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. The MAA is complicated by the need to consider both European economic integration and the independence of individual member states.

As a specialist in regulatory matters, Proregulations has extensive experience in the registration of drugs in the EU, supporting its clients at all stages from drug development to market access.

Proregulations is familiar with the MAA approval process, provides detailed interpretation and advice on EU drugs regulations, and develops application strategies for specific products and needs.

MAA mainly includes information on drug quality, safety, efficacy, and manufacturing and control processes. The expert team at Proregulations is skilled at preparing the modules of the MAA document in compliance with EMA guidelines, as well as conducting a comprehensive review and gap analysis of the document.

There are several strategies that manufacturers can use to obtain a MA in the EU. Proregulations supports the following ways to submit a MAA:

• National Procedure (NP)

Applicable to applications for authorisation on the market of a single EU Member State only.

• Centralized Procedure (CP)

With one application and one assessment, a single market authorisation covering the whole of the EU is obtained.

• Mutual Recognition Procedure (MRP)

Seeking approval in other EU countries for drugs already approved in one EU Member State.

• Decentralized Procedure (DCP)

For drugs not yet approved in any EU Member State, allowing manufacturers to apply for authorisation in multiple EU countries at the same time.

With offices across the EU, Proregulations can communicate effectively on behalf of its clients with the EMA and other health regulators to ensure that submitted applications are processed in a timely manner. In addition, Proregulations manages the full MAA lifecycle for customers, such as MAA revisions and MAA updates.

Proregulations understands the complexity and urgency of the marketing approval process for drugs in the EU and is committed to ensuring a smooth and efficient MAA process with the highest professional standards and service quality.

For details of Proregulations MAA services, visit the website: https://www.proregulations.com/eu-marketing-authorisation-application-maa.html

About Proregulations

As a leading provider of product consulting and regulatory compliance solutions, Proregulations is committed to providing efficient and customized solutions to various industries around the globe, including regulatory interpretation, policy consultation, document preparation and submission. Proregulations specializes in handling all regulatory issues for its clients from product development to application submission, until the final product is marketed.

Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, New Dietary Ingredients Compliance, FDA Agent Services, Medical Device Distributor License, TSCA Compliance, China Cosmetics Registration, etc.