Guidance for researchers and SMEs

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We have developed a series of guidance documents to assist you in translating your research discovery into an advanced therapy medicinal product or a therapeutic drug.

Crossing the Valley of Death

Guidance for translating a research discovery into an advanced therapeutic product (for Cell and Gene Therapies)

Translation from Discovery to Market

Guidance for translating a research discovery into an advanced therapeutic product (for Cell and Gene Therapies)

From Discovery to the Clinic

Guidance for researchers navigating the innovation pipeline from research discovery to therapeutic drug (small molecules)

Establishing a Quality Management System

A starting guide for research facilities wishing to establish a quality management system