Chemistry, Manufacturing & Controls (CMC)
While the tendency for emerging companies is to focus on completing and analyzing clinical trials prior to submitting a BLA or NDA regulatory filing, other parts of the drug development effort, such as CMC, are also critical to a successful filing and review.
CMC constitutes the part of pharmaceutical development that addresses and defines the nature of the drug substance and drug product, the processes in which both are made, and the manner by which the manufacturing process is shown to be in control. If scientifically justifiable arguments that support a product's CMC are not carefully developed, the risk of product or regulatory failure increases.
A great deal of foundational CMC work is done prior to the introduction of the therapeutic to humans. While this work can fulfill the initial development purpose, in many cases it may not be robust enough to fully define clinical and commercial ventures, nor to survive regulatory scrutiny.
Maxiom Group helps companies addresses this gap through its focus on ensuring that CMC-related capabilities and infrastructure are established, documented and scaled in a manner that supports a robust submission. In addition, Maxiom Group can support and facilitate the assessment and remediation of the state of CMC supportive work.
Maxiom Group works with CMC Teams and senior management to support the following areas:
- Process development and validation
- Manufacturing scale-up
- Clinical and commercial supply planning
- CMO sourcing and management
- Analytical methods validation
- Analytical methods development, validation and gap analysis
Our skilled practitioners provide emerging life science companies with the in-depth experience, insight, and capabilities they need to ensure the robustness of their CMC capabilities:
- Regulatory filing experience at emerging biopharmaceutical companies
- Experts in Regulatory, Quality, Manufacturing and R&D
- Experienced Project Management