Quality & CMC Support

What it is

Not every project needs a full-time CMC or quality function. When additional expertise is needed, we can help identify the right outside support for the scope, stage, and technical needs of the program.

Our network includes experienced consultants across CMC, quality, regulatory, manufacturing, and related disciplines. We make introductions based on the needs of the engagement so clients can work directly with specialists who are well suited to the work.

When you need it

Outside CMC or quality support can be useful when preparing for an IND or IMPD, transferring a process to a CDMO, establishing or strengthening a quality system, preparing for an audit or inspection, or filling a temporary expertise gap within a growing team.

It can also be valuable when a project requires a specialist perspective that falls outside the scope of ARCBio Consultants’ process economics work.

How we can help

• Identify the type of CMC or quality expertise needed
• Recommend trusted independent consultants and specialist firms
• Make introductions to partners with relevant technical and stage-specific experience
• Help define the scope before engaging an outside consultant
• Coordinate with external specialists when their work intersects with ARCBio Consultants’ process economics analysis

Trusted partners

We work with a network of experienced CMC, quality, regulatory, and manufacturing consultants. Selected partners are featured below.

LabScale AI

AI literacy training for life science teams, with workshops built around the documents and compliance requirements that CMC, quality, and regulatory groups work with day to day.