Syner-G provides CMC consultation to address drug substance (DS) and drug product (DP) development challenges. Closely working with the clients, we enable CMC decisions for important topics such as the selection of API starting materials, defining CPPs and CQAs, control strategies for genotoxic impurities, DS/DP specifications, stability protocols, QbD approaches to product/process design etc. We excel in providing these services for early to mid-stage biotech and pharma companies who use a virtual drug development model.
So, allow us to be your virtual CMC development organization, handling the strategic planning and tactical oversight needed to ensure efficient and timely CMC pharmaceutical development . We offer scientific and technical consultation along with project management support for process and product development, analytical method development and selection and management of contract development, manufacturing and testing sites for drug substances and drug products. Our expert consultants have real world experience in applying the state-of-the-art scientific and technological approaches and quality standards to develop the right quality target product profile (QTPP) for your drug and design the product and process using Quality by Design (QbD) principles.