CMC SERVICES
ANALYTICAL METHODS
DS InPharmatics is a full-service CMC consulting firm with experience and expertise in each of the sub-disciplines of Chemistry, Manufacturing and Controls (CMC).
Analytical Method Development and Validation
Analytical methods are the cornerstone for product identity and Quality Control analysis. DSI consultants work with Sponsors and contract laboratories (CROs) to ensure that methods (i) are scientifically sound and complaint, (ii) are suitable for transfer into commercial manufacturing environments, and are compatible with available equipment, and (iii) allow for easily traceable version control at all stages of development.
DSI consultants have a thorough knowledge of United States Pharmacopeia 25 (USP 25) and recognized analytical procedures for comparator and innovator products under section 501 (b).
DSI’s integrated Regulatory Affairs approach to data generation, method development, validation and change control ensures bridging back to early animal and clinical studies. We ensure that methods are robust, specific and precise, providing reliable data compliant with ICH guidelines and a clear understanding of the requirements and expectations at each clinical stage as well as ensuring that the data itself is accurate and reliable.
DSI’s consultants can help design forced degradation studies and review the data to ensure that methods are stability indicating and are validated at the appropriate time.