CMC Regulatory
Develop your Chemistry Manufacturing, Controls and beyond Strategy and Roadmap
A sound CMC regulatory affairs strategy is essential for any company developing a drug or biologic. Solid chemistry manufacturing controls, backed by clear evidence that they meet global CMC regulatory compliance requirements, often determine whether an application advances or stalls in costly delays. ADRES guides sponsors through every stage of CMC compliance planning, documentation, and regulatory dialogue.
Our specialists align your work with current standards and agency feedback, starting with early formulation and continuing through submission and post-approval change management. We help build practical, high-quality controls that support timely approvals and keep your product on track for launch and beyond.
| CMC | Early Stage | Pre-clinical | Clinical | Registration | Market |
|---|---|---|---|---|---|
| Define CMC strategy and roadmap |  | | |||
| Lead and support CMC gap assessments | | | | | |
| Lead and support: process development (&trouble shooting), process scale up, tech transfer, process risk assessments, comparability exercises, process characterization and process validation | | | | ||
| Contract Manufacturing Organization (CMO) selection and supervision including Person in Plant | | | |||
| Project management and coordination activities | | | | | |
| Writing and reviewing Module 3 for IND and IMPD submissions | | | |||
| Support with analytical method development and validation | | | |||
| Provide ongoing CMC support remotely and/or at client’s offices (including master and executed batch records review, etc.) | | | | ||
| Lead and support CMC inspection readiness and risk assessment processes | | |
What are the key components of an effective CMC regulatory affairs strategy?
How does CMC compliance affect regulatory submissions and approvals?
When should companies begin focusing on CMC regulatory affairs in the product lifecycle?
How can ADRES support your team with CMC regulatory compliance?
What are common pitfalls in chemistry manufacturing controls, and how can they be avoided?
Integrated Audit Services for End-to-End Product Compliance
ADRES provides audit services that span both regulatory strategy and manufacturing execution, ensuring alignment between product development plans and operational reality. Our audits are built around global GxP expectations including FDA, EMA, ICH, and PIC/S.
We offer:
- GMP Audits: Reviewing internal processes, CMOs, and suppliers for compliance and quality risk.
- Process Validation Audits: Assessing tech transfer readiness, scale-up protocols, and reproducibility.
- Analytical Method & Facility Audits: Ensuring laboratories, methods, and manufacturing sites meet compliance requirements.
These audits identify early-stage compliance risks, support submission readiness, and ensure smooth regulatory interactions. Contact us to strengthen your product’s compliance trajectory from lab to launch.
