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