Regulatory

The regulatory authorities of different countries adhere to their defined norms on processes and product quality. Hence, in order to market products in a specific country, a company requires plant & product approvals from the regulatory authority of respective country. We have in-house regulatory capability team to carry out dossier submission/filings across different countries in specified formats for registration.

The regulatory team has already obtained product registrations worldwide, including Regulated Markets of the USA & EU and Emerging Markets.

The team's capabilities include preparation of protocols with respect to ICH guidelines, identification, education & selection of study centers, regulatory procedures & approvals from government bodies, monitoring & recording data during study, as well as final report writing & statistical analysis of data.

With growing concern over drug safety, Pharmacovigilance becomes a mandatory practice, which is the science relating to detection, evaluation, understanding and prevention of adverse effects or any other likely medicine-related problems. Our Pharmacovigilance policy aims at improving patients’ safety and addressing the risks & issues related to drug safety, simultaneously easing out the regulatory compliances. We also submit the Periodic Safety Update Reports (PSUR) to respective regulatory authorities with proper product safety data analysis.

Our strength lies in our team comprising trained and committed manpower, who function in concurrence with processes and product quality norms of different countries of the Regulated as well as Emerging markets.