Chemistry Manufacturing Controls

CMC Drug Development and Operations Management

The chemistry, manufacturing and controls (CMC) experts at DSI provide consulting services that yield efficient regulatory approaches to pharmaceutical and biologics. We partner with you to develop your regulatory strategy, as well as author, prepare, review and submit CMC documentation for all phases of development. Our CMC experts have experience with complete analytical and formulation development programs, from initial development to production of clinical and commercial supplies for small and large molecules.

DSI’s early involvement in the drug development process saves you substantial time and money. From API and formulation sourcing, to manufacturing, scale-up and packaging, we provide invaluable strategic guidance and management services.

A Deeper Department

A Regulatory Drug Development consulting business that (works exclusively with) serves the needs of small emerging biotechs, most of whom do not yet have major products approved and on the market (to improve performance in strategy and leadership). Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC and Regulatory issues and build programs that enhance development.

INTEGRATED CMC DEVELOPMENT

Time- and cost-effective product development and registration demand that CMC activities keep pace with the stage of development and that the risks are identified and mitigated. The characterization of NCEs, establishment of adequate and development phase-appropriate impurity controls and specifications, and management of the supply chain, clinical supply, and commercial material must be in sync with the state of the science, the stage of development, commercial goals and constraints, and applicable laws and regulations. We provide our clients with development strategies that drive the overall product development process to meet milestones in a cost-effective manner.


Materials Characterization and Formulation Development

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DSI guides sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes. We have experience with small molecule and biotechnology products and the full range of dosage forms used in solid oral, inhalation, intranasal, topical, and parenteral administration.


Process Development, Optimization and Validation

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Experienced management of these activities ensures the quality of the materials being produced and the reliability of the clinical and commercial supply chain as it moves from bench-top through scale-up. We have experience with small molecule and biotechnology processes, including expertise in critical areas such as viral clearance strategies, excipient compatibility studies, and scale-up management.


Analytical Method Development, Optimization and Validation

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DSI can oversee the development analytical methodologies for use in the control of starting materials, drug substances, and drug products. This spans the full lifecycle of methodology including creation, optimization, transfer, and validation.


Stability Program Design and Management

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Due to the length of time required to conduct stability studies and obtain requisite data, stability program management requires diligent integrated planning and oversight. We are well versed in the regulatory requirements and statistical processes required to support commercially viable product expiry periods. This includes the ability to design stability studies, analyze results, and compile and effectively present the data.


Vendor and Contractor Identification and Management

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Selecting and efficiently managing vendors that are reliable, as well as technically competent, is one of the best tools available for minimizing the time needed to develop and register a drug or healthcare product. Contract manufactures, laboratories, and suppliers require diligent oversight and management so as to prevent development delays and cost overruns and to ensure the quality of products and deliverables. We work with vendors and clients to identify appropriate and place the required management processes to minimize the risks and maximize the value that these service providers can produce.

Our network of contract manufacturing organizations (CMOs) allows us to identify the most suitable service providers for your compound and dosage form and ensure optimal performance within your time and budget parameters. Throughout the process, DSI experts advise on formulation and design, handle site inspection/monitoring, design/review protocols and identify the best method validation strategy to ensure compliance with FDA and ICH guidelines — a critical step for first-cycle review.


Supply Chain Assessment And Management

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Product manufactures need capable oversight and development of clinical and commercial supply chain logistics to ensure a continued supply of goods to the clinic and the market. We provide logistical oversight from the acquisition of raw materials acquisition at the beginning of the process through to delivery of clinical materials to trial sites for developmental programs and distributors for commercial products.


CMC Regulatory Affairs Support

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As an investigational product moves closer to commercialization and final to market, the CMC information is collected, maintained, and updated for both the drug substance and drug product. We have prepared numerous successful CMC and quality sections of regulatory submissions including meeting packages, INDs and CMC Amendments, DMFs, NDAs, postapproval CMC Supplements, Canadian NDSs, BLAs, European IMPDs and MAAs, and postapproval variations IMPDs.