EMA (European Medicines Agency)

The EMA is the central regulatory authority for human and veterinary medicines in the European Union (EU). It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines that are marketed in the EU. The EMA works closely with national regulatory authorities in EU member states to ensure the safety and efficacy of medicines throughout the EU.
In addition to the EMA, each EU member state has its own national regulatory authority for medicines. These authorities are responsible for ensuring that medicines are safe and effective; and that they meet the same standards as those set by the EMA. They also work closely with the EMA to coordinate their activities and share information on the safety and efficacy of medicines.

Categories of Products/Who can Register ?

Our services are open to a wide range of stakeholders of the following categories under EMA regulations:

1. Pharmaceutical Companies
   We provide comprehensive support to pharmaceutical companies for product registrations, help ensuring compliance with EMA guidelines and regulations.

1. Manufacturers of Biologics
   Our experts assist in navigating the complex regulatory framework for biologics, help ensuring your products meet EMA's stringent requirements.

1. Medical Device Manufacturers
   We offer guidance to entities aiming to obtain EMA approval for medical devices, from classification to clinical evaluation and post-market surveillance.

1. Manufacturers of Cosmetic
   We assist in the regulatory process for cosmetic products, help ensuring compliance with the European Cosmetic Regulation.

1. Clinical Trial Sponsors
   Organizations planning to conduct clinical trials in Europe. Our services encompass clinical trial applications, approvals, and help in compliance with EMA's clinical trial regulations.