Global Regulatory Support

Global Regulatory Chemistry Manufacturing and Control (CMC) support through cross-functional interactions with client's manufacturing, clinical and therapeutic area teams for biotechnology products
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
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