Pre-Clinical Project and Strategic Planning - Research, evaluation and selection of CROs and testing and diagnostic vendors for pre-clinical processes. Provide leadership, expertise, and strategic planning for non-clinical drug evaluation, and Translational Medicine Planning expertise including biomarkers for clinical development
Pharmaceutical formulations – Drug substance QC and formulation expertise. Formulation evaluation and support
Chemical Process Research - CMC (chemistry manufacturing and controls) turning drug candidates into actual drugs, CMC Due Diligence assessor covering API, Drug Product and Analytical support.
Pre-Clinical Operation - Provide studies need assays to follow patients, and those assays must be validated by FDA rules. Provide project management and oversight of all pre-clinical activities being performed at locations outside the Biotech facilities.
After outsourced to CRO and assay is validated. To validate assay, we will create these documentations (SOPs, protocols, statistical calculations by FDA standards, data driven reports, DMR, DHF, Design Control documents etc).
Provide Design Control knowledge needed to plan and manage preclinical and clinical activities.
Manage all preclinical studies related outsourcing studies, including but not limited to:
Drug Safety Evaluation - Provide project management and oversight of:
Business Stimulant Consultants, LLC
3240 Henry Hudson Parkway
Riverdale, NY 10463