A rapidly expanding global biological solutions company aspired to develop an ideation to registration framework to accelerate product development from R&D to registration and commercialization.
Commercial and technical resources were being added in multiple countries with minimal awareness of other products being developed outside their specific country/region.
An early stage pharmaceutical client acquired an asset with Phase 2B cardiovascular data and a goal to repurpose the drug for a rare disease indication.
The client required regulatory and clinical expertise to support a type B meeting request with the FDA.
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 pharmaceutical company received numerous FDA 483’s and/or a Warning Letter(s) related to continual non-conformance of the company’s quality management systems with respect to current Good Manufacturing Practices (cGMP).
A large pharmaceutical company sought to accelerate a product launch timeline.
The client needed to transition their drug product manufacturing process from small scale batch equipment used for Phase 1 and 2 clinical supplies to a continuous manufacturing process to accommodate larger than originally anticipated commercial volumes.
A modular continuous manufacturing platform capable of smaller production and rapid scale up for an ‘on demand’ supply paradigm was needed.