Strategic navigation of the evolving life sciences landscape is critical to ensuring delivery of transformative technologies to patients. Successfully bringing innovation to patients requires the support of a deeply experienced and committed interdisciplinary team that focuses on the unique legal, regulatory, compliance, operations, and technology matters facing innovative life science organizations. Epstein Becker Green (EBG) has a unique focus on the health care and life sciences industries. We have assembled a multidisciplinary team of more than 100 attorneys, along with a network of consultants and advisors, many of whom have worked inside life sciences organizations and government agencies and have experienced the reality of translating legal advice to practical action. 

The diversity and breadth of experience of our Life Sciences team enables us to successfully meet the needs of our life sciences clients from early pre-clinical research to commercialization/product launch and through commercial operations and compliance over the entire product development lifecycle. EBG’s attorneys partner with our affiliates, EBG Advisors, a consulting firm providing real-world advice on regulatory and compliance matters, and National Health Advisors, a lobbying firm providing policy support and advocacy on Capitol Hill. Our focused and integrated approach provides the practical and comprehensive support life science companies need as they discover, develop and commercialize novel medical technologies to meet the needs of patients. 

EBG represents companies across the spectrum of the life sciences industry including (among others):

  • pharmaceutical manufacturers,
  • biotechnology companies,
  • medical device manufacturers,
  • in vitro diagnostic innovators,
  • HCT/P manufacturers,
  • clinical laboratories,
  • digital health companies,
  • research services vendors including contract research organizations (CROs) and site management organizations (SMOs),
  • academic centers,
  • research institutions and investigators,
  • trade associations and industry coalitions, and
  • investors in the Life Sciences industry.

Our team members regularly interface with regulatory authorities, research organizations, academic institutions, clinical sites, CROs, provider networks, and other third-party suppliers. We assist with the strategic planning for clinical trials including product specific research and application strategy; research related policies, procedures and training; and negotiating the terms of research collaborations. We help our clients establish collaborative relationships with universities and other research institutions in the creation of new products from molecule discovery to the commercialization of approved products. We partner with our clients as they transform from development to commercial stage organizations, helping build commercial ready compliance programs, FDA-compliant marketing and sales programs and legal infrastructure for market access and reimbursement, among other things. 

Our Life Sciences team covers a broad scope of products and services that fall within the following general categories:

Research and Development

  • Clinical trial strategy and protocol development
  • Licensing, collaboration and joint ventures
  • Material transfer arrangements
  • Animal research
  • Human research subject protection
  • FDA Regulatory
  • USDA Regulatory for Animal Diagnostics

Clinical Research Support

  • Global clinical trial site contracting
  • Human subject research protection
  • Collaborative research alliances and contracting
  • Medical Affairs support
  • Research, educational, and charitable grant support
  • Compassionate use and extended use arrangements
  • Vendor contracting
  • CRO services
  • FDA regulatory

Product Commercialization

  • Promotional review
  • Products liability / risk mitigation
  • Safety/pharmacovigilance
  • Supply chain
  • Licensing
  • Commercial contracting
  • Market Access:
    • Reimbursement landscape assessments and strategy
    • Coding, coverage & payment counseling
    • Payor contracts
    • Government contracts / rebate agreements
    • Government pricing calculations and compliance
  • Distribution:
    • FDA/DEA/state regulatory compliance counseling
    • Licensure and registration support
    • Supply and distribution agreements
  • FDA regulatory

FDA Regulatory Strategy

Regulatory strategy, product development and product approval:

  • Regulatory pathway assessments
  • Clinical trial strategy and protocol development
  • Good Manufacturing Practice (GMP) compliance
  • Regulatory submissions (both support/counsel and full production of submissions) such as:
    • Jurisdictional Submissions: Request for Designation (RFD), Pre-RFD, 513(g)
    • Development Phase Submissions: Pre-IND, Q-Submission
    • Investigational Phase: IND, IDE, Risk Determinations, IRB submissions
    • Marketing Submissions: NDA (including 505(b)(2)) and ANDA, BLA, 510(k), De Novo, PMA
    • Regulatory Appeals of adverse decisions
  • Agency advocacy

Post approval compliance:

  • Sales and marketing compliance
  • Pharmacovigilance and adverse event reporting
  • Imports/exports
  • Quality assistance assessments and investigations
  • Recalls
  • Risk Management
  • Patient Assistance Programs

FDA inspections and enforcement:

  • Regulatory authority inspection readiness
  • FDA Form 483 warning letter responses and remediation
  • Criminal and civil enforcement defense
  • Government investigations

Compliance and Training

  • Fraud and abuse counseling
  • Stark law counseling
  • Promotional strategy and material review
  • Corporate compliance program development
  • Government pricing and government contracts compliance counseling and assessments
  • Clinical operations and product commercialization compliance counseling and assessments
  • Compliance program gap analysis, risk assessments and investigations
  • Development and implementation of auditing and monitoring plans
  • Consumer privacy compliance
  • Domestic and international anti-bribery and anti-corruption law counseling 
  • Enforcement remediation and defense

Litigation

  • Government investigations
  • White Collar
  • Federal Foreign Corrupt Practices Act
  • Commercial Litigation

Transactions and Capitalization

  • Mergers, acquisitions and divestitures
  • Joint ventures
  • Business formation/start-up activities
  • Financing transactions:
    • Private placements of equity
    • Debt/loan transactions
  • Corporate reorganizations and restructurings
  • Regulatory due diligence
  • Regulatory landscape assessments
  • Reimbursement landscape assessments

We regularly work with companies operating in the following fields/areas: