Product Development
CMC Outsourcing Support
Helping you navigate complex discovery, selection, and management needs
Our subject matter experts guide you in all phases of finding, engaging, and managing a CDMO. We create tailored evaluation criteria designed around your day-to-day needs as well as your short- and long-term business goals. Our services will:
- Identify, evaluate, and select CDMOs based on fit for project and client
- Review and help negotiate master services agreements
- Manage CDMOs and advocate on behalf of client to achieve desired outcome and deliverables
We also support and oversee the following processes:
- Cell line, process, and formulation development
- Development and validation of analytical methods for in-process, release, and stability
- Design specifications for release of bulk drug substance and products
- Clinical filling of drug products
- Clinical packaging, labeling, and distribution
- Process validation
- Commercial manufacturing
Why choose Alira Health?
Our team has more than a decade of experience guiding companies through biologics development. As our partner, you’ll benefit from:
- Comprehensive, integrated CMC services that deliver holistic solutions tailored to your business needs and goals
- Knowledgeable industry leaders who deliver scalable, actionable insights
- Close collaboration and clear communication from engagement to launch