Clinical Trial Authorisations (CTA)
Investigational New Drug Applications (IND)
Investigational Medicinal Product Dossiers (IMPD)
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The regulatory planning of a clinical trial programme is a speciality all of its own. Now the global clinical development programmes are the norm you may find yourself conducting a single protocol in twenty or more countries, and even if most of them are members of the EU that doesn't mean they process applications for clinical trial authorisation in the same way. They don't even all have the same data requirements. With considerable experience in this field, Akos is able to guide you through the regulatory legislation in the EU, US and other key territories so that you don't end up with your first centre completing before the last on has started.
Akos can help with
- Preparation of IMPDs and Investigator Brochures
- Assistance with Ethics Committee submissions
- Country selection for clinical trials
- Preparation, assembly, submission and management of applications for Clinical Trial Authorisations, including first time in man, throughout EU and US
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk