Our Team

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Our Team

Meet our Expertise Team

Alexander Johnson

Founder & Principal

Shailesh Joshi

Adviser

Alexander Johnson

Founder & Principal

Strategically adept at navigating through complex global regulatory environments, Dr. Joshi has successfully led regulatory submissions and approvals across key markets, including the U.S. (FDA 510(k), De Novo), Europe (MDR/IVDR), Canada, Latin America, the Middle East, Oceania, and Asia. He is known for driving cross-functional collaboration, accelerating time-to-market, guiding geo expansion and ensuring product compliance and success. He is masterful at technical documentation, risk management, leading clinical studies, and helps companies streamline processes. Dr. Joshi has a Ph.D. in Biomedical Engineering from the University of Strathclyde, UK. He is also an inventor of multiple industrial patents. Holding the Regulatory Affairs Certification (RAC), he is an active member of RAPS (Regulatory Affairs professional Society).

Shailesh Joshi

Founder & Principal

Mr. Shailesh Joshi is a seasoned regulatory and quality expert with experience across innovative medical devices, IVDs, OTC drugs, and cosmetics. With a career spanning MedTech, Life Sciences, and FMCG sectors, he has played a pivotal role in the development and launch of therapeutics, cancer diagnostics, and consumer healthcare products, managing the full product lifecycle from development through to post-market strategy adhering to compliance.
Strategically adept at navigating through complex global regulatory environments, Dr. Joshi has successfully led regulatory submissions and approvals across key markets, including the U.S. (FDA 510(k), De Novo), Europe (MDR/IVDR), Canada, Latin America, the Middle East, Oceania, and Asia. He is known for driving cross-functional collaboration, accelerating time-to-market, guiding geo expansion and ensuring product compliance and success. He is masterful at technical documentation, risk management, leading clinical studies, and helps companies streamline processes. Dr. Joshi has a Ph.D. in Biomedical Engineering from the University of Strathclyde, UK. He is also an inventor of multiple industrial patents. Holding the Regulatory Affairs Certification (RAC), he is an active member of RAPS (Regulatory Affairs professional Society).