The Regulatory Affairs departments at Kusum Healthcare ensure that the company complies with all of the regulations and laws concerning the business. It is an important part of the organisational 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 the company conducts its business activities.
Their involvement is key in the development of new products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to concerned health authorities and is actively involved at every stage of development of a new product and in the post-marketing activities with authorised medicinal products.
Our 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 questions and briefing documents, attend the meetings and manage all communication with the health agencies.
At later stages of product development, it is responsible for the submission of the registration dossier, e.g. Marketing Authorization Applications (MAA) in the respective countries. Our team specialises in managing the communication and negotiations with the authorities and is accountable for maintenance of marketing authorizations and the life-cycle management of a product.