Regulatory Affairs

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The Regulatory Affairs department is an important part of the organizational structure in Ashish Life Science.

We view the Regulatory Affairs team as a pathway to new markets. Increasing investment in this team has resulted in a greater number of product registrations across the globe, thus acting as a catalyst for growth. We have an experienced and capable team that internally liaises at the interface of drug product development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities / clients of respective countries wherever company have business activities.

Regulatory Affairs at Ashish Life Science is involved in the development strategy of new products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to regulatory authorities. They keep a close eye on the ever-changing regulatory guidelines to ensure our procedures and documents are compliant with country-specific guidelines.

Regulatory team ensures that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right form. Regulatory team at Ashish Life Science is actively involved at every stage of development of a new product and in the post-marketing activities with authorized medicinal products.

At the later stage of product development, regulatory affairs department is responsible for the compilation and submission of the registration dossier in the respective countries and to answer the queries raised time to time by the concerned regulatory authorities. Regulatory team manages the communication and negotiations with the authorities.

Regulatory team at Ashish Life Science is accountable for maintenance of marketing authorizations and is involved in the life-cycle management of a product.



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