A regulatory team is in place to prepare and compile all the documentations required to register products in various geographic locations and to answer the queries raised time to time by the concerned registration authorities.
products are subject to regulations designed by governments to protect public health.
The Regulatory Affairs departments of Kusum Healthcare ensure that company complies
with all of the regulations and laws concerning business. The Regulatory Affairs
department is an important part of the organizational structure in Kusum Healthcare.
Internally it liaises at the interface of drug development, manufacturing, marketing
and clinical research. Externally it is the key interface between the company and
the regulatory authorities of respective countries wherever company have business
activities. Regulatory Affairs at Kusum Healthcare is involved in the development
of new products from early on, by integrating regulatory principles and by preparing
and submitting the relevant regulatory dossiers to health authorities. Regulatory
team at Kusum Healthcare is actively involved at every stage of development of a
new product and in the post-marketing activities with authorized medicinal products. Regulatory
Affair contributes essentially to the overall success of drug development, both
at early pre-marketing stages and post-marketing stages.
Regulatory professionals ensure that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right form. They develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents, attend the meetings and manage all communication with the agencies. At the later stage of product development, regulatory affairs department is responsible for the submission of the registration dossier, e.g. Marketing Authorization Applications (MAA) in the respective countries. Regulatory team manages the communication and negotiations with the authorities. Regulatory team at Kusum Healthcare is accountable for maintenance of marketing authorizations and is involved in the life-cycle management of a product.