Life Science Legal’s Services
Our clients rely on us for tailored advice for fundamental life sciences company needs. We have the experience and flexibility to tackle everything from more significant, complex transactions and regulatory issues to more routine day-to-day legal work of the type typically seen by in-house counsel.
Life Science Legal provides you with the comprehensive support you need in a pragmatic, efficient and cost-effective manner.
Practice Areas
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TRANSACTIONAL
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GENERAL AGREEMENT SERVICES
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CLINICAL/RESEARCH AND DEVELOPMENT
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SUPPLY CHAIN
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COMPLIANCE AND REGULATORY
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PRODUCT LAUNCH SUPPORT
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INTELLECTUAL PROPERTY
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OUTSIDE GENERAL COUNSEL SUPPORT
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GENERAL CORPORATE
Transactional
Life Science Legal provides expert, trusted advice for complex commercial transactions including:
- In- and out-licensing
- Strategic alliances and collaborations
- Joint ventures
- Co-promotion and co-marketing relationships
- Technology transfer
- Due diligence examinations of life science companies and products
- Acquisitions and divestitures
- Strategic advice and transaction structuring
General Agreement Services
Life Science Legal provides efficient and pragmatic legal oversight of routine company contracting needs including:
- Commercial, vendor and purchasing agreements
- Outsourcing agreements
- Material transfer agreements
- Master Services Agreements
- Confidentiality agreement
- Consulting Agreements
- Employment agreements
- Real estate lease agreements
- Preparation and review of template agreements
Clinical/Research and Development
Life Science Legal provides the advice and support your company needs to advance its R&D and clinical trial programs including:
- Clinical trial agreements
- Sponsored research agreements
- Informed consent forms
- Agreements with CROs
- CRADAs
- Laboratory Services Agreements
- Providing advice on legal and regulatory issues relating to clinical trials and R&D
Supply Chain
Life Science Legal provides expert advice and support for the full range of supply chain activities including, the sourcing, manufacturing, packaging, supply and distribution of products and components. Services include:
- Product development agreements
- Feasibility agreements
- Platform and drug delivery technology agreements
- Manufacturing and supply agreements
- Packaging Agreements
- Provide advice on recalls and other corrective actions
- Provide advice on supply chain and manufacturing issues
Compliance and Regulatory
The life science industry presents a unique and complex compliance and regulatory environment. Life Science Legal leverages its deep industry experience to provide the compliance and regulatory advice your company can rely on. Services include:
- Serve as member of Compliance Committee
- Serve as member of Grants Review Committee
- Provide counsel and strategic advice to companies on compliance and regulatory issues including:
- FDA regulations
- PhRMA Code
- Product promotion
- Healthcare fraud and abuse/Anti-kickback laws
- Payments to HCPs
- HIPAA and privacy laws
- Sunshine Act/Aggregate Spend
- State pricing transparency laws
- Provide advice on patient assistance and co-pay support programs
- Audit and monitor speaker programs and promotional activities
- Provide counsel and strategic advice to brand teams on sales and marketing initiatives, strategies, programs and practices
- Provide advice on sales force compliance
- Conduct compliance training including sales rep and supervisor training
- Compliance needs assessment and implementation
- Provide strategic advice on developing and structuring compliance programs
- Draft and implement policies and procedures
- Provide support for compliance training and education
- Provide support for compliance auditing and monitoring
- Serve as the legal reviewer to advertising and promotional review committees
Product Launch Support
Life Science Legal regularly supports clients in navigating the complexities of successful product launches. Our services cover a wide scope of pre- and post-launch activities including:
- Rebate, managed care and formulary agreements
- Agreements with wholesalers and distributors
- Compliance Program Implementation
- Review and approval of promotional and non-promotional material
- Intellectual property advice and strategy
- Compliance and regulatory advice
- Review of website content
- Provide counsel and strategic advice to companies looking to enter the U.S. market
Intellectual Property
Life Science Legal can help ensure proper management of your critical intellectual property assets. Services include:
- Patent and trademark searches
- Patent and trademark procurement, licensing, and litigation
- Development, protection and monetization of patent, copyright and trademark portfolios
- Patent and trademark due diligence
- Freedom to operate analysis
- Intellectual property management and strategy
Outside General Counsel Support/In-House Legal Services
Life Science Legal provides on-site or remote support of your company’s day-to-day legal needs whether acting as your outside general counsel or as an adjunct to your existing legal team. Services include:
- On-site support of day-to-day legal operations
- General agreements
- Serve on Advertising /Promotional Review Committee
- Serve on Grants Review Committee
- Serve on Compliance Committee
- Serve as corporate secretary
- Contract management tool, policy and process implementation
General Corporate
Life Science Legal provides advice and support for forming and managing your company. Services include:
- Choice of entity and corporate formation
- Corporate governance
- Serve as corporate secretary
- Serve as a board member
- Manage corporate board meetings
Large Firm Expertise, Boutique Efficiency
Our deep industry expertise coupled with the efficiency and responsiveness of a smaller firm makes us perfectly positioned to become a valued member of your team.
