Simpex pharma Pvt. Ltd. having a good and skilled personnel team responsible for establishment of procedures of various regulatory authorities, both domestic and international markets.
Regulatory teams cover a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. We Simpex Pharma Pvt. Ltd. regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold.
The regulatory affairs involvement is 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.