The company's regulatory team has a sound and complete understanding of international regulatory requirements, and has several key regulatory approvals to its credit.
The team has been able to obtain over 100 product registrations worldwide so far. Marketing Authorization Applications have been filed in regulated markets including the USA, European Union countries, Australia, New Zealand etc.
The team develops formulations for generic products in accordance with the most stringent regulatory requirements. Formulation studies, method development and validation, study on container closure systems and stability studies are conducted in line with international guidelines.
The clinical trial team's capabilities include preparation of protocols in line with ICH guidelines, identification, education and selection of study centers, regulatory procedures and approvals from government bodies, monitoring and recording data during study, as well as final report writing and statistical analysis of data. The team carries out both clinical trials as well as bio-equivalence studies.
