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The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.
Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.
Regulators’ review of a Clinical Trial Application (CTA) is
A number of regulatory provisions, structures and procedures aim at increasing the development of medicines for use in children.
Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.