Launching a drug development company with novel technology from academia
Our corporate group has worked with hundreds of entrepreneurs at this stage to help them optimally and efficiently select and form the appropriate legal entity
Client Groups
Companies Developing and Commercializing Pharmaceuticals
At Faber, our integrated team of lawyers and contracts specialists have helped our clients launch hundreds of clinical trials, and collectively they’ve worked on over 10,000 CTAs.
Overview
Effective preparation, negotiation and deployment of service agreements for pre-clinical laboratory services, formulation and development, and cGMP manufacturing of drug substance and drug product for clinical and/or commercial use requires experienced legal counsel that understands the industry-specific drivers of a complex supply chain.
We have a large team working in this practice, including many lawyers who have been executives or in-house legal counsel for fast-growing technology companies. So we understand how a contract’s fine points can affect a company’s operations and what it takes to successfully conclude these agreements.
Our process is unique among law firms
Experienced contract specialists work alongside attorneys steeped in the business side of life sciences. Prior to joining our firm, team members have held full-time positions with hospitals, biotech and pharmaceutical companies, and contract research organizations (CROs). Collectively, they have worked on tens of thousands of clinical trial agreements worldwide.
We can leverage our experience to guide you through a contracting process that’s tailored to your project.
We’ll factor in:
- Your in-house clinical capabilities
- Trial protocol
- Characteristics of enrollment sites, whether U.S.-based or foreign, academic centers or private practices
- Capabilities of your CRO
Based on an in-depth understanding of your situation, we can deliver a full range of clinical trial contract services, including:
- Customizing form agreements
- Strengthening and tailoring CRO-provided templates
- Creating and negotiating individualized clinical trial agreements
- Reviewing informed consent forms
- Negotiating CRO service agreements
- Negotiating clinical trial supply and distribution agreements
