Global Regulatory Support
Global Regulatory Chemistry Manufacturing and Control (CMC) support through cross-functional interactions with client's manufacturing, clinical and therapeutic area teams. We are working with any type of biologics, including biotechnology products, ADCs, vaccines, cell and gene therapies, and any new therapeutic modalities.
Strategic planning
Regulatory strategic planning, CMC gap analysis, authoring of regulatory submissions (Module 3): PIND packages, INDs, IMPDs, pre-BLA packages
Analytical data monitoring
Coordination of work by SMEs and production facility teams upon client's needs. Professional analytical data monitoring, regulatory assessment of change controls and deviations, identifying risks with appropriate contingency strategies
Intellectual Property counseling
IP counseling and protection. U.S. patent drafting and prosecution
