Reg­u­lat­ory services

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Reg­u­lat­ory services

Our ISAR Bioscience reg­u­lat­ory team has many years of expert­ise in plan­ning pre­clin­ical and clin­ical devel­op­ment pro­grams. We pre­pare doc­u­ments, dis­cuss study plans and res­ults with clin­ical experts and sub­mit dossiers to reg­u­lat­ory author­it­ies and eth­ics com­mit­tees. We are happy to make this expert­ise avail­able to other teams in aca­demia and the biotech industry.

As part of our ser­vice, we draft and final­ize the rel­ev­ant doc­u­ments and sub­mit them to the rel­ev­ant bod­ies. These include, for example, Investigator’s Bro­chures (IB), Invest­ig­a­tional Medi­cinal Product Dossiers (IMPD) and Clin­ical Trial Protocols.

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