“The complexity of our work required a fair bit of legal services expertise and Noelle Byrnes was able to maneuver us through it with a great deal of care and clarity while ensuring we were aware of the process.”
– Senior Manager, Finance
Legal Services
The life sciences sector is rapidly evolving, and Noelle Byrnes of Byrnes Law has the experience, knowledge, business acumen and offers legal services to help clients reach their goals. We provide strategic oversight to navigate legal complexities throughout the lifecycle of your product.
Research & Development
Services
- Joint Venture & Strategic Alliances
- Vendor RFPs and Evaluations
- University Licensing
- IP & Collaboration Agreements
- Scientific Advisory Boards
- Laboratory Services
- Evaluation & Feasibility
Clinical
Services
- CRO Engagement
- Clinical Trial Agreements
- Institutional Review Board (IRB) Submissions
- Consent Forms & HIPAA Authorizations
- Letters of Indemnification
- Clinical Trial Subcontract Agreements
Regulatory & Compliance
Services
- Compliance Program Development Support
- FDA
- Federal Anti-Kickback Law
- GXP Regulations
- Stark
Commercial
Services
- Manufacturing & Supply
- Development & Distribution
- Technology Licenses
- Asset Purchases
- Distribution
- Product Marketing