Mahnu Davar is a trusted partner to lawyers, compliance officers, regulatory professionals, and business executives across the life sciences industry. Mr. Davar counsels clients on mission-critical FDA, CLIA, fraud and abuse, and state licensing regulatory matters, including compliance program development and management. He routinely assists multinational companies with sensitive internal investigations, regulatory inspections, product quality and safety issues, data integrity concerns, and government enforcement matters. He also assists clients, particularly in the diagnostics and medical technology fields, with developing regulatory lifecycle strategies.
Mr. Davar's clients include biotechnology startups, major clinical laboratories, and some of the world's largest pharmaceutical and medical technology companies in the oncology, ophthalmology, and pain care spaces. His practical, interdisciplinary approach to counseling is informed by prior secondments in the legal departments of major life sciences companies where he has acted as the lead commercial lawyer for several blockbuster biopharma and surgical product franchises. Mr. Davar is a lecturer at Penn Law School, a Fellow of the Salzburg Seminar, and a former Fulbright Scholar to India.
- Counseling several biopharmaceutical companies in connection with clinical data integrity remediations, including to lead internal investigations, developing regulatory reporting or response strategies, and working with data security consultants to implement CAPAs.
- Advising several biopharmaceutical companies on regulatory and compliance issues arising from cellular and gene therapy products.
- FDA, CLIA, and healthcare compliance counsel to several high complexity laboratory technology companies.
- Counseling several medical technology companies on regulatory and compliance issues arising from real world evidence study design and clinical trial designs.
- Regulatory and compliance counsel to private equity fund owners of medical technology companies.
- Assisted senior leadership of several medical technology and biopharmaceutical startups to establish compliance governance infrastructure, including board charters, compliance investigation and non-retaliation procedures, and corporate policies and codes intended to “marry” new business and compliance cultures.
- Counseling pharmaceutical companies on compliant payor communications and interactions under the new 21st Century Cures legislation.
- Assisting several biopharmaceutical and medical technology companies to build or enhance healthcare compliance programs, including policies, procedures, training modules, and monitoring systems.
- Advising several specialty pharmaceutical companies and medical device companies on clinical and pharmacoeconomic research compliance issues, including site contracting, payments to healthcare providers (HCPs) and institutions, GCPs/data integrity, and site inspection readiness.
- Counseling clinical lab technology companies on FDA and CLIA compliance matters.
- Representing several pharmaceutical and medical technology companies as FDA/healthcare regulatory deal diligence counsel.
- Advising major technology and manufacturing company on FDA regulatory implications of set-up of medical device technology subsidiaries.
- Advising pharmaceutical companies on compliance and disclosure obligations under Corporate Integrity Agreements, Deferred Prosecution Agreements, and Consent Orders/Decrees.
- Counseling pharmaceutical and medical device companies in connection with regulatory and compliance aspects of significant contract manufacturing, contract research, and product distribution arrangements.
- Led compliance risks assessments of sales, managed markets, medical affairs, and R&D operations for several biopharmaceutical companies.
- Represented pharmaceutical manufacturers, medical device manufacturers and distributors, medical technology developers, clinical lab, and major academic research institution in connection with routine and for-cause cGMP, QSR, BIMO, and CLIA inspections.
- Conducted significant multinational compliance review of biopharmaceutical company's medical, R&D, and drug safety functions.
- Helped lead training programs for hundreds of employees across Finance, Legal, Compliance, and business functions in Europe, Asia, and the Americas in connection with anticorruption program development and implementation.
Healthcare: Service Providers (2017)
- JD, University of Pennsylvania Law School, 2007
- MA, University of Pennsylvania Center for Bioethics, 2007
- BA, Johns Hopkins University, 2003, with honors, Phi Beta Kappa
- Fulbright Scholar, India
- District of Columbia
- US District Court, Eastern District of Pennsylvania
Member, The District of Columbia Bar, Health Law Section
Fellow, Salzburg Global Seminar
Lecturer in Law, University of Pennsylvania Law School
- Fellow, Leadership Council on Legal Diversity (LCLD)