Life Sciences Regulatory Counseling & Compliance

Experience

Counseled a Pharmaceutical Company on Compliance Program Development and Implementation

Client: A Pharmaceutical Company

Advised a clinical-stage pharmaceutical company regarding its transition to commercial stage, including the development and implementation of a corporate compliance program. This included training company executives on compliance and regulatory matters, drafting and reviewing compliance policies and procedures, reviewing promotional materials, advising on implementation of a transparency tracking/reporting program consistent with federal and state laws, and advising on compliance and regulatory matters. 

Conducted a Compliance Review and Assessment of a Biotechnology Company’s Corporate Compliance Program

Client: A Biotechnology Company

Assessed the implementation and effectiveness of a biotechnology company’s corporate compliance program, including review of company policies, procedures, guidelines, training materials, risk assessment processes, internal investigation reporting mechanisms and follow-up, and auditing and monitoring activities. Also made recommendations for enhancing the program and assisted with implementation of such recommendations.