Life Sciences Regulatory and Compliance
Life sciences companies face an unprecedented level of scrutiny in the legal, regulatory, and compliance arenas. Drawing on our wealth of experience and substantial bench depth, Porzio helps life sciences companies navigate this ever-changing landscape. We understand the challenges facing life sciences companies and are passionate about finding compliant, creative, and cost-effective solutions.
Porzio provides a wide array of compliance and regulatory counseling services to pharmaceutical, medical device, and biotech companies at every stage of development.
- Counsel clients on anti-kickback considerations and compliance with industry standards
- Develop compliance manuals, policies, and standard operating procedures
- Prepare audits, gap analyses, and risk assessments of companies’ compliance policies to identify potential gaps and necessary additional policies and procedures
- Conduct on-site and remote management and sales force training and prepare all training and follow-up materials
- Serve as members of promotional review teams, particularly during product launches
- Conduct gap analyses of the distribution license status of existing or newly acquired businesses
- Serve as an on-site adjunct to the legal or compliance department and work directly with the business people to realize the company's business and compliance objectives