Chemistry, Manufacturing, and Controls (CMC) is a critical part of the drug development process. Swiftwater Group has extensive expertise in developing CMC strategies, working with contract manufacturing organizations (CMO), and creating documentation for global regulatory submissions for both drug substance and drug product. CMO Vendor Selection Swiftwater Group helps clients identify the most appropriate CMOs for the manufacture and supply of drug substance and drug product for non-clinical, clinical, and commercial supply. We go beyond the simple documentation and negotiation processes by helping clients identify objectives, performance metrics, and potential manufacturing issues to ensure the chosen vendor will be able to respond with appropriate flexibility. Recommend vendors to respond to Requests for Proposal (RFPs) Identify best-in-class vendors depending on the client’s product, needs, and timelines Document and deliver RFPs to identified CMOs Communicate necessary milestones and performance metrics Ensure that technical information and program expectations are clear and accurate Conduct site visits to vendor finalists, including GMP and QA inspections Thoroughly analyze vendor’s capabilities "Stress test" vendor for ability to manage changes in scope Negotiate favorable contract with selected vendor(s) Ensure contracts cover contingencies and problem resolution methods After vendors are selected, Swiftwater Group can continue to act as a liaison with the vendor to ensure strict adherence to timelines and protocols. CMC Technical Advice Swiftwater Group can offer a range of consulting services within the CMC realm: Project Management Evaluation of characterization and analytical data for regulatory acceptability Process development and optimization Pre-formulation and formulation Analytical method development, validation, and protocol review Technology transfer Stability study design and review of stability data Scale-up CMC Supporting Documentation Development Swiftwater Group has a deep understanding of the detailed format and content regulations for CMC documentation required by the regulatory authorities and can provide specific or turnkey services in their preparation. DMF/EDMF/CDMF preparation and maintenance CMC portions of IND and NDA/BLA (Modules 3 (Quality) and Module 2 Quality Overall Summary for the CTD) Certificate of suitability Quality Management (GMP) To support the CMC program of a drug development project, Swiftwater Group offers a complete package of Quality Management services. For more information, see our Quality Assurance Services page.