Our Expertise

Our in-house expertise on determining the appropriate global regulatory market entry strategy and can support in preparing
regulatory dossier 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, CDSCO -India),
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 currently leads the Technical and Management Department. A businesswoman by profession, she brings 17 years of experience across the pharmaceutical, food, medical device, and IVD industries. She serves as a regulatory expert for IIT Mumbai, providing consultation support to startups and medium-sized companies. A qualified Lead Auditor, Ms. Ganapathy has conducted more than 80 audits, including international audits with USFDA auditors in alignment with 21 CFR 820 requirements. She has also received specialized training in packaging testing, biocompatibility, and preclinical studies at Underwriters Laboratories, Germany. She is supported by a strategic advisory team comprising GLP experts, clinical specialists—including doctors and physicians from renowned hospitals—as well as regulatory experts covering China, the US, the EU, Korea, and Taiwan. This team provides guidance and assistance on a case-by-case and time-to-time basis. Employees are assigned tasks based on their creativity, industry knowledge, experience, and interpersonal skills.