Orbit CMC Inc.

Orbit CMC Inc offers consulting activities for Small Molecules Developments from Drug Discovery stage to Drug Product Registration. Strategic CMC Integration is essential for a successful submission. The CMC focus changes along each development stage. High quality data in the early stage of development is critical in order to support the development of the drug. Analytical method development, Physico-chemical characterization, Salt form selection, Bio-analytical development, pre-formulation, Solid state characterization, Forced Degradation studies design are key elements for a solid drug development. Scale up of the API involve Process Development, Analytical Method Validation and Transfers, In Process Control implementation, Specification set up based on F&P studies and alignment to the Regulatory Requirements. Identification of the Critical Parameters based on a Quality by Design approach will save precious time in the development process. Impurities control and Regulatory Starting material strategies are determined based on scientific approach. CMC support for the regulatory submission is essential. Hands-on expertise on multiple analytical techniques is providing confidence of the data interpretation. Evaluation of Regulatory Agencies requests and meetings support is also provided.