Pre-Clinical Development Services

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:

  • Contract negotiation
  • Study design and protocol development
  • Assay development and validations
  • Study monitoring
  • Interpretation of study results
  • Study report review and finalization
  • Biomarker selection
  • Bioinformatic/computational biology expertise for personalized medicine & segmentation of patient population


Drug Safety Evaluation - Provide project management and oversight of:

  • Safety Pharmacology
  • General toxicology
  • Genotoxicity
  • Reproductive toxicity
  • Carcinogenicity (two years)
  • Toxicokinetics(Bioanalytical)

Where to Find Us:


Business Stimulant Consultants, LLC

3240 Henry Hudson Parkway

Suite 7E

Riverdale, NY 10463

Phone: 917-482-5642

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