The PLG Life Sciences Team provides a full-service range of skills and experience across the life sciences industry, including biotechnology, bioenergy, medical devices, and nutraceuticals. We provide experienced counsel for transactions, compliance, and global operations in life sciences and healthcare, and counsel public and private companies at all stages of development through the entire product lifecycle — from early-stage discovery and clinical development to manufacturing, commercialization, and post-market compliance.
Key Services Overview
Corporate
- Entity formation, structuring, financing, and tax planning
- Strategic transactions, partnerships, affiliations, and joint ventures
- Commercial contracting, clinical development, and operational agreements
- General counsel and corporate governance support
- Securities compliance and government contracting
- Nonprofit and tax-exempt organization
Intellectual Property
- Patent strategy, prosecution, portfolio management, licensing, and life-cycle management for pharmaceuticals, biologics, and other innovations
- Freedom-to-operate analyses, product clearance assessments, research collaborations, and IP due diligence for transactions and M&A
Employment
- Employment agreements, handbooks and policies Investigations, audits, trainings and advise and counseling
- Employment litigation, including class action and representative matters
- Executive compensation and employee benefits
Immigration
- Non-immigrant visas/status, and immigration pathways and permanent residence (including for entrepreneurs, investors, scientists and other highly-skilled professionals)
- Citizenship and nationality services
- I-9, e-Verify and compliance programs
- Global mobility and cross-border transfers
International Trade & Compliance
- Cross-border transactions, investments and partnerships
- Risk management and compliance programs for multinational operations
- Distribution/supply chain relationships and due diligence
- Export controls compliance; tariffs and customs counseling
Regulatory Counseling
- Regulatory counseling in healthcare and FDA-regulated industries
- Pharmacy law
- Risk assessment
- Government audit response and support
- Compliance program development and implementation
Litigation & Investigations
- Complex business litigation
- Defense of OTC drug product labeling class actions
- Alternative dispute resolution
Data Privacy & Cybersecurity
- Data governance for health and clinical data
- Strategic process guidance to ensure operational data protection
- Policy review and advice
- HIPAA and Non-HIPAA health data legal compliance
- Sponsorship agreements, Informed Consent Forms (ICF), CDAs, international data transfer agreements and broad consent
Enforcement Defense
- False Claims Act defense
- White collar defense