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Our non-clinical staff has first-hand experience of working in both a non-GLP and GLP environment as a study director and monitoring scientist.

We can deliver the necessary input in the preparation of non-clinical components of key regulatory documents including Investigator’s Brochures, periodic- and expert reports, global product labeling, and product monographs.

Besides working with you to ensure that all studies are conducted in compliance with all necessary regulations, we can help you compile the necessary non-clinical input in the preparation of regulatory documentation such as an IB, CTA/IND, Briefing Book and MAA/CTD.

François van Och

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François van Och

Managing Partner, Non-Clinical Team Lead

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