Compliance and Regulatory Counseling
Life sciences companies today 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 partner with life sciences companies to help patients while accomplishing the business goals of the company. We understand the challenges facing life sciences companies and are passionate about finding compliant, creative, and cost-effective solutions to these challenges.
Porzio provides a wide array of regulatory compliance counseling and defense services to pharmaceutical, medical device, and biotech companies at every stage of development. Some examples of the counseling and assistance we provide include:
- 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 license status so that new products may be distributed upon FDA approval or new acquisitions can immediately contribute to their parent companies’ success
- Serve as an on-site adjunct to the legal or compliance department and work directly with the business people to realize the company's legal and compliance objectives.