Our Expertise

Our in-house expertise on determining the appropriate global regulatory market entry strategy and can support in preparing
submission files which comply to specific local regulations. Whether it relates to listing your devices in databases or
filing complete regulatory submissions (i.e. CE submissions, FDA submissions),
our experts are ready to assist.

Our Team

The initial management team depends on the proprietor, with a few highly skilled employees. In future, we will take on additional people in areas like Marketing,Technology etc. At present we have a strong team of four marketing person on and off the field and we have industry experienced expertise and advisors in the respective field who assist the company in key areas of Consultation, Design Development, Implementation, Regulatory Requirement, Testing support and quality process compliance, if the project involves high complexity. Our employees are highly skilled to handle any exigency.

Ms. Divya Ganapathy is presently handling the department of Technical, HR and business development. She is a business woman by profession and has 14yrs of experience in the Medical Device and IVD industry. She is a Regulatory expertise for IIT Mumbai and provide consultation support for the startup and Medium sized based companies. She is a qualified Lead Auditor and has conducted more than 50 audits. She has also conducted audit with USFDA auditors as a part of 21 CFR 820 requirement. She is trained in Packaging testing, Biocompatibility and Preclinical studies at Underwriter Laboratories, Germany. The strategic advisory team comprises of GLP expertise, Clinical Expertise which includes Doctors and Physicians in a renowned hospital, Regulatory expertise in India and US, Korean Regulatory Expertise and Taiwan. They actively assist her on a time-to-time and on a case-to-case basis. Employees are given specific tasks based on their creativity, knowledge, experience in the industry and their social ability.