Genesis Pharma - Products

The Regulatory Affairs department of GENESIS Pharma ensures the effective management of regulatory requirements for the entire product portfolio and at all stages of a product’s lifecycle, capitalizing on the deep scientific knowledge and experience of its specialized, highly trained professionals.

It safeguards the compliance of both products and company functions with all applicable laws, regulations and directives of the pharmaceutical regulatory framework. It serves as the company’s liaison with local and international Regulatory Authorities for obtaining and maintaining the marketing authorizations of its products, cooperating with all global partners and the company's representative offices to this end.

The Regulatory Affairs department works closely with all business units aiming to help them fully comply with regulatory guidelines that affect their activities and transform regulatory requirements into applicable and operational plans. Its ultimate goal is to support the company's vision for patient access to innovative therapies with high standards of quality, safety and efficacy.