Preclinical section of the marketing authorisation dossier

Modules 2.4 and 2.6 (Non-Clinical Overviews and Summaries)/Expert Reports

Profit from our preclinical documentation experience – and our precise knowledge of the regulatory requirements. Module 2.4 of the Common Technical Document (human medicinal products) and Safety and Residues Expert Reports (veterinary medicinal products) centre on the areas pharmacology, pharmacokinetics, toxicokinetics, toxicology and Maximum Residues (veterinary). Our experts collate your investigational findings and scientific documents, and retrieve existing material from bibliographical sources and databases. Module 2.6 contains (human) precisely defined summaries of the preclinical investigation reports.

The right basis for your marketing authorisation

The regulatory basis has a determining influence on the degree of detail and the focal points of Modules 2.4 and 2.6 (human) and Safety and Residues Expert Reports (veterinary). The structure and content of these modules differ considerably, depending on whether you are seeking authorisation for a completely new product, a generic product or a product containing known substances. By the same token advanced therapies and other high-tech products raise issues that require special attention. The same applies to phytopharmaceuticals.

Our team of pharmacists, physicians, toxicologists and veterinarians can draw on an extensive body of experience and promote the regulatory acceptance of your product during the preclinical phase, while at the same time paying full attention to clinical observations.