CMC Services

Strategic CMC Compliance for Drug Development Success

CMC (Chemistry, Manufacturing and Controls) compliance is a critical element of your drug development success. Regulatory expectations evolve throughout clinical development, requiring a phase-appropriate and product-specific approach. Your CMC strategy also needs constant alignment with your clinical and marketing strategy. In addition to regulatory complexities, factors such as process scalability, process and analytical performance, costs, and the coordination of multiple manufacturing and testing sites introduce challenges that continuously shape CMC strategy . An agile and proactive planification is essential to ensure regulatory compliance despite such a number of risk factors. Early involvement of regulatory compliance in your drug development can save you time and money. Our CMC services can be tailored to your needs.

CMC Strategy

Depending on your product’s development stage, we assist in formulating an initial CMC strategy to establish a solid foundation or in conducting a gap analysis of your existing CMC data package or development plan.

CMC Operational Support

Control strategy
Successful drug manufacturing requires the establishment of a phase-appropriate control strategy, covering both process controls and product controls. The set of controls is derived from the current product and process understanding that ensure process performance and product quality. A phase-appropriate approach ensures that as clinical development progresses, increasing process knowledge leads to robust process validation for marketing approval.

We assist in designing an operational control strategy

Determination of CQA (Critical Quality Attributes) and QTPP (Quality Target Product Profile)
Identifying the CQA of your products (DS, DP, Diluent, Starting material, Excipient) is the starting point to create a control strategy. The CQA are linked to the quality target profile of the final drug product to be achieved (e.g. dosage form and strength, route of administration, clinical setting, container closure system, delivery system).
Product controls
DS/DP release tests, DS/DP stability programs, In-Process Controls for product quality attributes, non-routine characterization testing
Process controls
Process parameters (CPP, KPP, Non-CPP), IPC for control of process parameters (performance attributes), release and stability of starting materials and raw materials

Misalignment between a sponsor’s strategy and a CDMO’s documentation or operational execution can create inconsistencies, leading to regulatory challenges. Discrepancies in data reporting (e.g. rounding of final data, release versus characterization test category), sampling strategies, manufacturing scale selection, and more. Continuous alignment with the manufacturing and testing sites is key to avoiding questions on inconsistencies from Regulatory Authorities during the review of applications or to ensure the most streamlined and efficient process development phase.

Manufacturing Process Development
Changes to your manufacturing process are inherent and part of your drug development. We help you in organizing a structured versioning system of your manufacturing process and in recording the changes in a format readable by Regulatory Authorities.
Analytical Methods review support
The performance of analytical methods required for your product varies based on their intended use (e.g. release versus characterization), clinical stage, quality attribute category, required precision as per acceptance criteria set for the specifications, reference materials. We can review the performance (initial requirements, plan for the chosen method or results) of your analytical methods:
- Review of Analytical Target Profile (ATP)
- Review of Analytical method Validation/ Qualification protocol
- Review of Analytical Method Validation/ Qualification report

CMC Technical Writing

Regulatory dossiers require a broad set of source documents from various stakeholders (e.g., CDMOs, internal teams). Based on your overall CMC strategy, we can help you develop the list of documents. Early involvement in reviewing the source documents helps streamline dossier preparation. We offer hands-on support for writing or reviewing some of the key documents. Here below is a non-exhaustive list of documents:

Justification of Specifications (including rationale for changes)
Process Flow Chart or Process Flow Diagram
Risk Analysis
Adventitious Agents Safety Evaluation
Product Comparability
Development Reports
Story behind selection of your drug candidate or design of your manufacturing process. It is very typical for very early-stage drug development not to have all required historical reports. Some CDMO may provide unofficial updates or may use slide decks in lieu of development reports. You may also lack the appropriate identification of pivotal process or analytical development studies and the definitive conclusions used to drive the development and transfer the information in a controlled environment.
Characterization Report
Batch Data Compilation
You may miss the overview of all accumulated data inside a manufacturing run. We can help you consolidate them using batch record, analytical reports for IPC, characterization and release tests.

We specialize in writing the IMPD or CTD Module 3 for clinical applications. See “CMC Regulatory dossiers” for more details.

Troubleshooting CMC issues

CMC-related challenges can arise at any stage of development, from manufacturing deviations and analytical discrepancies to regulatory non-conformities. Addressing these issues through both reactive problem-solving and proactive risk mitigation is essential to maintaining development timelines and avoiding regulatory roadblocks.

CMC Due Diligence

We offer CMC due diligence services to assess the regulatory and technical robustness of your product’s CMC development, whether for internal evaluations, licensing opportunities, or investor assessments. Our due diligence support includes the following elements:

Reviewing the regulatory history of the product, assessing past scientific advice and recommendations
Evaluating implementation feasibility and risks associated with prior regulatory commitments
Identifying potential gaps or weaknesses in existing CMC data packages
Assessing risks and opportunities related to manufacturing scalability, analytical robustness, and regulatory compliance
Providing strategic recommendations to strengthen the CMC package and mitigate risks before investment or licensing decisions

CMC Regulatory dossiers

Our expertise in CMC strategy, operational execution, and troubleshooting naturally extends to the preparation and submission of CMC regulatory dossiers. We provide writing or reviewing services for:

CMC sections for Scientific Advice Briefing Book (including identification of CMC-related questions, background section, and sponsor’s position)
IMPD or CTD Module 3, whether for initial submissions or amendments (including compilation of changes with rationale)
Assistance in responding to CMC-related regulatory queries

See our Regulatory Affairs Services for additional support in interactions with regulatory agencies (lien vers les services de type Regulatory Affairs)

Need support in Other CMC Activities?

If you require specialized CMC support not explicitly written above, please reach out