CMC SERVICES
PROCESS DEVELOPMENT
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).
Process Development and Validation Services
Our CMC consultants fully understand the factors that need to be considered during scale-up and technology transfer to clinical and commercial production. We review product development, batch records and validation procedures. We also conduct cGMP audits to ensure that contract manufacturers (CMO) are compliant with current regulatory requirements and that drug products are representative of clinical and planned commercial production.
DSI process development scientists work with CMO’s to identify and develop key control parameters and specifications for processing procedures used for mixing, granulation, compression, coating and filling of solid and semi-solid dosage forms, as well as for solutions, emulsions, suspensions, and sterile parenteral products. Our extensive manufacturing experience allows for practical approaches to the development of QbD driven Design of Experiments (DOE) which enhance real understanding of how process variables affect product quality.
Most importantly, DS InPharmatics can translate this information into a cohesive drug development narrative that will meet regulatory reviewer expectations for understanding and communicating the scientific rationale behind critical process parameters, specification justification, and release testing, while at the same time fulfilling current Quality by Design (QbD) initiatives.