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
Leading New Law with Porzio Life Sciences
For more than 15 years, Porzio Life Sciences, a wholly-owned subsidiary of Porzio, Bromberg & Newman, has been providing industry-leading products and services to clarify the compliance process for companies of all sizes and across all jurisdictions. Our legal clients often benefit from the information and technology that is provided by Porzio Life Sciences including having access to Porzio Compliance Digest, the go-to source for compliance professionals looking for regulatory analysis of global, federal, and state life sciences laws relating to the marketing and sale of pharmaceuticals and medical devices.
Comprehensive Risk Management Platform
Our products and services come with a unique feature: the comfort of knowing that they were designed by experienced lawyers and regulatory experts. Their knowledge is the foundation of every aspect of the Porzio Life Sciences platform, making users more effective in all aspects of compliance, from transparency reporting to distribution licensing to privacy issues. With PLS solutions “built from the law,” your compliance team is empowered to take a proactive approach to risk management.