The nature of work of the Regulatory Affairs Department at Pharmathen S.A. encompasses a close scrutiny of all technical data generated during the development of the product, including the manufacturing methods, quality control procedures, clinical safety and efficacy leading to a collation of this data and the compilation of dossiers in line with the stringent requirements imposed by health authorities regarding the format of marketing authorisation applications.

Conformance to such requirements is ensured through constant updates on current and future regulatory expectations, so that all scientific projects carried out are conducted according to satisfactory regulatory standards. Our Regulatory Affairs Staff keeps up to date on all systems and requirements in all the company's export markets, whether it is Europe, a large and highly regulated pharmaceutical market, or countries outside the E.U. for which no international harmonisation has as yet occurred.

The Regulatory Affairs department ensures the appropriate licensing, marketing and legal compliance of pharmaceutical products. The department employs 10 scientists including pharmacists, chemists and biochemists. Combining knowledge of scientific, legal and business issues, we enable products that are developed, manufactured or distributed by Pharmathen S.A or other companies to meet the required legislation.

Regulatory affairs officers are the crucial link between Pharmathen, its products and worldwide regulatory authorities.
The latest and most advanced regulatory strategies for dossier submission in EU and worldwide are being incorporated into the framework of the Regulatory Affairs Department.

Typical work activities include:
	Dossier submission for marketing authorization of new products, handling of variations and renewal procedures
	Liaison with regulatory authorities
	Compliance of products with the current regulations
	Continuous monitoring of international legislation, guidelines and customer practices.
	Medical Information for the production of labels and patient information leaflets
	Planning and communication with CROs for clinical trial studies.
	Advice to other science departments on specific regulatory issues.
	Research of specifics on new products prior, during and after product development.

For more information contact
	Angeliki Schina Responsible for Europe
	Chrysoula Fazou Responsible for Developing Countries
	Valanta Tsoukia Responsible for Greece
	Ioanna Constantopoulou Responsible for Canada, Australia, USA.