CMC Consultancy
Due to the diverse nature of CMC development and the diversity in candidate medicinal products, the team of CMC professionals at Kinesis Pharma were specifically assembled to provide broad and in-depth CMC expertise. CMC consultants focus on addressing the strategic and technical aspects of chemical and pharmaceutical development. This process typically starts with the design of an integrated CMC development plan. The CMC development plan details the CMC Regulatory Affairs (RA), cross-functional and scientific strategy relevant to the stage of development from chemical- or cell line development, analytical method development and validation, formulation development, setting of specifications, stability studies, up to manufacturing and distribution of clinical trial material (CTM). The plan also addresses the strategy for manufacturing of the investigational medicinal product (IMP) for toxicology material and clinical trial supplies (CTS). Once the details of the CMC development plan are agreed, the next important step is the selection of a contract manufacturing organization (CMO) and contract research organizations (CROs). CMC consultants are skilled at managing and supporting (contracted) CMC activities to deliver the goals of the CMC development strategy throughout the drug development program.
CMC consultants provide independent advice e.g. due diligence, gap analysis, define (or review) the CMC development strategy and trouble-shoot technical challenges.
In addition, CMC consultants participate in multidisciplinary compound development teams and/or assist sponsors by managing in-house CMC development activities with onsite support. In instances where the sponsor requires the expertise of the CMC consultant on a temporary basis to fulfil an in-house function, interim management services are provided e.g. CMC Manager, Head of CTM Manufacturing, Head of Analytical Development, Head of Formulation Development, Head of Chemical Development, Qualified Person (QP), etc.