Life Sciences Legal, Regulatory, and Compliance
Porzio, Bromberg & Newman provides life sciences companies with the counsel they need to succeed at every stage of their journey, from conception to clinical trials to commercialization and beyond.
Our attorneys bring a highly practical and collaborative mindset, shaped by years of in-house and hands-on experience with pharmaceutical, medical device, and biotech companies, to the evolving legal, regulatory, and compliance challenges our clients face. Ranging from multinational manufacturers of pharmaceutical, biotech, and medical device products in various disease sectors to venture-backed start-ups, rare disease companies, and gene therapy providers, our clients seek our life sciences attorneys for assistance at all stages of the product lifecycle. Clients benefit from our history of forward-thinking in the life sciences space, evidenced by our recognition from the Financial Times as its 2023 Innovative Lawyers in Healthcare and Life Sciences award winner for our development of Porzio Life Sciences (now a strategic partner under separate ownership).
Today, life sciences companies are confronted with unprecedented challenges, heightened by governmental emphasis on enforcement and compliance. Our experience with a broad universe of life sciences company types allows us to provide benchmarking data offering valuable perspective for decision-makers. Meanwhile, our ability to provide comprehensive solutions is bolstered by collaboration across diverse practices within Porzio, spanning employment, privacy, licensing, corporate, and litigation. As a mid-size law firm, we possess the agility to act swiftly and efficiently while also providing the attorney-client privilege and other benefits that distinguish us from more limited service offerings in the industry.
Porzio addresses legal, regulatory, and compliance matters, including building comprehensive compliance programs. Our experience covers:
- Clinical trials, including agreements with CROs and sites and investigators;
- Commercialization, including market entry and distribution compliance, commercial agreements and promotion, price transparency, training of field personnel and incentive compensation plans, marketing plan audits and social media training, and post-market oversight;
- Medical affairs, including research grants, promotional materials, MSLs, communications and publications;
- Corporate communications, including media packages, website compliance and social media communications;
- Launch activities, including press releases, policies and SOPs, training programs, materials review, price transparency considerations, programs, contracts, audits and assessments;
- Distribution, including licensing compliance, wholesaler and market-entry contracts;
- Interactions and engagement with HCPs, including speaker programs, advisory boards, consulting and publication agreements, and compliance training;
- Interactions with patients and patient organizations, including patient advocacy interactions, patient outreach and privacy compliance;
- Compliance programs, including risk assessments, audits, business rules and training; and
- Grants, sponsorships, and donations.
For life sciences companies in need of legal, regulatory, and compliance support, Porzio has the knowledge and business-focused mindset to guide you toward your goals. Alongside our legal services, the consultants at Porzio Compliance Services (PorzioCS), a wholly-owned subsidiary, provide invaluable guidance and practical strategies for addressing compliance gaps and facilitating smooth operations while meeting regulatory requirements.
