Clinical Trial Support

Supporting You in this Evolving Area Through Our Team of Regulatory Experts

We have a team of Regulatory Affairs Experts with experience in the development of new therapeutic products and the Regulatory processes to be followed to place medicinal products on the market across the globe.

Our Regulatory Experts Can Support:

The Development of Appropriate Regulatory Filing Pathways

Interpret the Legal and Regulatory Landscape

The Design of Interventional and Non-Interventional Studies

Preparation of Clinical Trial Agreements, Investigational Medicinal Product Dossiers, and Investigational New Drug Applications for Clinical Trials

Preparation of Marketing Authorisation Applications and New Drug Applications to Support Medicinal Product Licensing

Interactions with Regulatory Authorities

Development of Drug Master Files

Authoring of Common Technical Dossier Documentation to Support the Registration of New Medicines

Preparation of Internal Standard Operating Procedures and Work Instructions