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 for CMC Outsourcing?
As our client, you can rely on Alira Health’s dedicated, knowledgeable team to lead and support your outsourcing activities. You’ll benefit from our:
- Extensive industry outsourcing expertise in the identification, evaluation, and selection of CDMOs, and managing the relationship with CDMOs to ensure that the client’s needs are met
- Strong technical management at all stages from preclinical process development through manufacturing
- Commitment to client advocacy with vendors that drives holistic solutions tailored to your business needs and goals
- Full spectrum development support from product decision through clinical trials, process validation, and commercial manufacturing
- Packaging, labeling, and shipping support and management