Develop your Chemistry Manufacturing, Controls and beyond Strategy and Roadmap
CMC experts initiate their work from early stages of development and become increasingly central and key functions as the product matures.
Our CMC experts know how to define your strategy and roadmap, find creative approaches to overcome challenges, and assist you with the required implementation.
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?
An effective plan blends sound science, disciplined risk management, and strict CMC regulatory compliance. Core elements include well-defined chemistry manufacturing controls, phase-appropriate process validation, robust analytical methods, and a clear comparability approach. Early dialogue with regulators and a living regulatory roadmap keep the dossier current and reduce last-minute surprises.
How does CMC compliance affect regulatory submissions and approvals?
Inconsistent or incomplete data is a leading cause of technical holds, major objections, and complete response letters. When chemistry manufacturing controls are applied consistently and documented under firm CMC regulatory compliance, reviewers can assess quality without repeated queries. Strong CMC compliance shortens review cycles and lowers the risk of post-approval commitments.
When should companies begin focusing on CMC regulatory affairs in the product lifecycle?
Work starts as soon as a development candidate is selected. Phase-appropriate planning in Phase 1 sets specifications, analytical methods, and stability programs on solid footing, preventing costly re-validation later. Early attention to chemistry manufacturing controls also supports seamless tech transfer, informed facility selection, and timely scale-up for pivotal studies.
How can ADRES support your team with CMC regulatory compliance?
ADRES delivers end-to-end help: gap assessments, control-strategy design, CTD Module 3 authorship, agency briefing packages, audit readiness, and post-approval change management. Our specialists translate regional guidance into practical work plans, coordinate with CDMOs, and coach internal teams so every submission meets the expectations of regulators and investors under strict CMC compliance.
What are common pitfalls in chemistry manufacturing controls, and how can they be avoided?
Frequent issues include unclear raw-material specifications, inadequate process-performance qualification, incomplete stability data, and weak change control. By applying deep CMC regulatory affairs expertise and proactive oversight, ADRES helps clients build reliable controls and maintain continuous CMC compliance throughout development and commercialization.
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.
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.