The nature of work of the Regulatory Affairs Department at Benzochem 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 by Benzochem  or other companies to meet the required legislation.

Regulatory affairs officers are the crucial link between Benzochem, 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.

 
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