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?
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
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