Rajesh Misra Email & Phone Number

I’m driven by timely access to high-quality, safe, and effective pharmaceutical and medical device products for patients globally. I work with life sciences organizations to solve their most pressing quality, regulatory and operational challenges across the entire product life cycle, from R&D, Manufacturing, and Commercialization. I advise clients on current good manufacturing practices (“cGMPs”) and quality systems, post-market surveillance and safety reporting, and recalls. I’ve assisted clients in re-designing their quality systems to not only improve efficacy but also transform them into fundamentally a more proactive and predictive quality systems for future using emerging technologies. I led several engagements in support of regulatory, quality, supply chain, and manufacturing transformations related to mergers, acquisitions, and divestitures. I've also worked on several regulatory-driven transformations, including US Drug Supply Chain Security Act (DSCSA) and EU Medical Device Regulation (EU MDR), among others for leading life sciences organizations. I’m passionate about digital health technologies and working with clients to find regulatory, quality, and commercial pathways to bring these therapies to patients. I’m a Principal in KPMG LLP’s Operations practice and lead our Quality and Regulatory services for life sciences industry.

Listed skills include Integration, It Strategy, Enterprise Architecture, Business Process, and 32 others.