As of May 1st, 2004 EC Directive 2001/20/EC became applicable across the EU Member States. Article 19 of this Directive requires non European sponsors of drug clinical trials to appoint a so called ‘Legal Representative’ that has to be legally established in the European Union.

MT Promedt Consulting offers the service of a ‘Legal Representative’ to its clients.

In addition MT Promedt Consulting can help with a wide range of regulatory services from the preparation of regulatory submissions to interfacing with regulatory authorities

Together with our regulatory expertise we also provide GMP batch certifications by a Qualified Person as required by the Directive. By partnering with a specialized Clinical Trial GMP laboratory these combined services ranging from preparation of clinical trials application (CTA) to GMP production audit and batch release will help to speed up the preparation of your clinical studies in Europe.

MT Promedt Consulting offers the following services:

• Acting as a Legal Representative for non-EU sponsors of clinical trials
• Acting as the interface between European regulatory agencies and the sponsor
• Strategic regulatory consulting on European regulations and requirements
• Compilation of applications for Ethics Committees
• Compilation and submission of Clinical Trial Applications (CTAs)
• Study entry in EudraCT database
• Importation, labeling and distribution of clinical trial supplies
• Submission of SUSAR reports
• Compliance with post-study regulatory requirements