Regulatory CMC Documentation refers to the collection of technical documents that describe the chemistry, manufacturing, and control aspects of pharmaceutical products. These documents provide detailed information on the characterization of active substances, formulation composition, raw materials, manufacturing processes, in-process controls, analytical methods, stability data, and quality management practices. Regulatory CMC documentation is essential for supporting regulatory submissions, demonstrating product quality, ensuring manufacturing consistency, and facilitating lifecycle management across the development, approval, and commercialization of drugs.
Chemical and Manufacturing Control (CMC) is a global term used by the FDA to describe drug production and testing data. CMC documents are documents prepared in accordance with the guidelines for Industry, Analytical methods and Verification procedures (Chemical, Manufacturing and Control documents) for analytical methods and validation procedures related to drug manufacture, These documents were published by the Centre for Drug Evaluation and Research and the Centre for Evaluation and Research of Biological products in August 2000 and have any finalized or follow-up guidelines. CMC is an integral part of drug development, regulatory submission, and continuous marketing and life cycle management of pharmaceutical products. As the drug development of the dosage form moves from concept to commercialization, the breadth and depth of the CMC documents required in the submission increase. All submitted regulatory documents require CMC data, such as:
Our team provides end-to-end support across the entire product lifecycle, ensuring that all CMC documentation not only meets regulatory requirements but also reflects robust quality management practices. We assist in optimizing process development, validating analytical methods, and implementing in-process controls to ensure consistency and compliance. Additionally, our guidance on QbD and CQA reporting supports systematic risk management and process understanding, while a thorough review of cGMP/GMP files ensures all records, reports, and procedures align with industry best practices. These services are designed to facilitate regulatory submissions, demonstrate product quality, and enhance operational efficiency throughout manufacturing and development processes. To achieve this comprehensive support, our Regulatory CMC Documentation covers the following key areas:
Characterization of active substances.
Analytical methods and specifications for the inspection and release of raw materials.
Formulation composition.
Method development and validation for analytical and release testing.
Raw materials for the production of active substances and finished dosage forms.
In-process control.
Description of product and process development.
Containers and containment systems.
Production process description.
Advise on Quality by Design (QbD) programs and requirements for regulatory filing, including developing CQA reports.
Release and stability test data of active substances and dosage forms.
Review cGMP/GMP files, such as verification reports, analysis methods, batch records, stability procedures, etc.
To ensure comprehensive and high-quality CMC documentation, our team leverages a wide range of analytical technologies and instrumentation. These capabilities enable precise characterization of active substances, identification of impurities, stability assessment, bioanalytical evaluation, formulation testing, and process monitoring. By integrating these analytical capabilities, we provide robust, reproducible data to support regulatory submissions and quality management throughout the product lifecycle.
Table.1 BOC Sciences' Functional CMC Technical Capabilities.
| Technical Area | Functional Description of the Technical Process |
| API & Custom Compound Synthesis | Confirms the molecular structure, evaluates purity, and analyzes component properties of active substances and APIs, ensuring structural integrity, consistency, and reproducibility, and providing foundational data for CMC documentation. |
| Impurity & Degradation Analysis | Systematically detects and quantifies potential impurities, degradation products, and metabolites; assesses the impact of manufacturing and storage processes on product quality, ensuring safety and stability. |
| Stability Testing | Evaluates changes in active substances, formulations, and intermediates under various environmental conditions, including release profiles, physicochemical properties, and particle stability, providing scientific evidence for shelf-life and storage conditions. |
| Biologics & Protein Characterization | Performs comprehensive characterization of biological products' structure, purity, and functional activity, including peptides, proteins, and antibodies, to ensure product integrity, quality control, and compliance with complex biopharmaceutical CMC documentation requirements. |
| Formulation Design & Performance Testing | Assesses dosage form performance, including particle size, rheological properties, release characteristics, solubility, and content uniformity, ensuring compliance with design specifications and quality standards. |
| Process Development & Control | Monitors critical process parameters and manufacturing operations in real time, evaluates process stability and controllability, and provides data for process validation, risk management, and process optimization in CMC documentation. |
BOC Sciences' CMC documentation services cover a wide range of drug categories, supporting data preparation and technical documentation across different stages of development:
Includes conventional chemically synthesized drugs and their formulations, such as tablets, capsules, injectables, and oral liquids. Services encompass process development, impurity studies, formulation design, and stability assessment, ensuring comprehensive and well-organized data.
Covers monoclonal antibodies, peptides, vaccines, recombinant proteins, fusion proteins, as well as cell and gene therapy products. Focus is placed on systematic characterization of complex manufacturing processes and quality attributes, helping clients establish complete data sets.
Sustained-release tablets, extended-release capsules, and other modified-release dosage forms fall under complex formulations. Our team supports the optimization of these formulations to achieve consistent performance and reliable quality. Detailed technical documentation captures formulation design, critical process parameters, and analytical characterization.
Inhalation products, liposomes, nanomedicines, implants, and other advanced delivery systems represent the forefront of innovative drug administration. We assist in process scale-up, technology transfer considerations, and preparation of comprehensive documents that describe formulation attributes, manufacturing processes, and key analytical findings.
The development of active pharmaceutical ingredients involves chemical or biological synthesis, process development, and scaling. Our services include impurity profiling, data organization, and preparation of documentation with clear process descriptions and traceable records.
Critical intermediates used in drug synthesis require detailed tracking and documentation. We provide structured records of synthesis routes, process control points, and analytical data, offering a complete technical overview for each intermediate.
Products that combine drug and device components present unique documentation needs. Our team delivers tailored technical records, capturing formulation, device elements, and process details to support efficient project management and development.
Some products integrate multiple therapeutic modalities or cross scientific fields, such as companion diagnostics. We organize technical and analytical documentation in a structured manner to help clients streamline development and preparation for regulatory submissions.
At the project initiation stage, we engage in in-depth discussions with clients to fully understand sample types, development stage, analytical objectives, and any specific requirements. Based on this information, we provide a customized service plan that defines the scope of work, data organization methods, analysis modules, and delivery schedule, establishing a clear foundation for subsequent tasks.
Clients provide experimental data, process information, and related materials according to project needs. Our team systematically organizes, classifies, and conducts a preliminary review of all materials to ensure completeness and traceability, preparing for the CMC documentation process.
Following the confirmed project plan, the technical team prepares each module of the documentation, including characterization of active substances, formulation composition, process description, analytical methods, and stability data. Throughout the process, we maintain continuous communication with clients, verifying data and incorporating feedback to ensure accuracy, logical structure, and clarity.
Once the draft is complete, the technical team conducts multiple rounds of internal review to check data completeness, consistency, and readability. Through this rigorous quality control process, the final deliverables clearly present development processes and analytical information, making them easy for clients to reference at different stages.
The final documentation is delivered in electronic format or the client's preferred format. We also provide technical interpretation and support during document use, allowing clients to efficiently reference the materials for ongoing development or submission preparation.
Our scientists have extensive experience in global pharmaceutical regulation, due diligence, research, development, technology transfer, commercialization, life cycle management and compliance. We have a strong documentation team dedicated to global and Chinese submissions to support the regulation of CMC documents. Moreover, CTD formats with version control or custom CTD formats can provide high quality to meet local requirements. Furthermore, comprehensive services for drug development and application are further ensured through the integration of IND-based toxicological, clinical, and regulatory services. BOC Sciences offers precise and thorough CMC documentation services, ensuring seamless data integration and clear technical communication. Our professionals deliver customized documents that support effective knowledge transfer and accelerate project timelines.
Our services are applicable to small-molecule drugs, biologics, and complex formulations. They are applicable to CMC documentation preparation and updates across the entire product lifecycle, from early-stage development to late-stage registration.
Yes. We can systematically organize and supplement the existing data and provide the necessary technical support to ensure the completeness and compliance of submission materials.
The delivery timeline depends on the project scale, complexity, and client requirements. After thorough communication, we strive to provide high-quality deliverables as quickly as possible.
Yes. In addition to preparing the initial CMC documentation required for submission, we also provide ongoing support and updates for supplemental applications, variations, and lifecycle management.
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