NGT experts, together with our network of quality CROs, CDMOs and CMOs, provide drug substance, drug product and analytical strategic advice compliant with regulatory and ICH guidelines for:
CASE STUDY – API and Drug Product Development Strategy
A start-up company with an asset ready to enter Phase III enlisted our support to create a product development report. The company also requested support in presenting the CMC strategy, including steps to be taken to achieve their commercialization target cost of goods, to a potential partner.
A development report outline was created to assess status of the project end-of-Phase 2 clinical studies. A digital validation lifecycle management solution was introduced to fulfill validation requirements for Stage 1, 2, and 3 including customized risk and knowledge management adjustments going forward. A regulatory and technology development framework including levers to reduce cost of goods was provided to the potential partner.
API and DP development reports were drafted, providing risk assessment inputs, to guide completion of the CMC development in parallel with the Phase 3 clinical studies. A gap assessment of information required for CTD submission was completed: critical process parameters, critical quality attributes, material attributes, regulatory starting material strategy. A cost of goods reduction proposal was endorsed by the commercial partner.