Pre-Clinical Translational Medicine, GAP& competitive analysis, solutions.

Non-Clinical/Clinical Pharmacology & Safety Analysis; dose & escalation justification, dose/schedule optimization justification.

Risk Management: Pre-Clinical, Clinical, Pharmacology, Safety, Efficacy& Regulatory Acceptance.

Clinical Trial Development strategy & planning, Trial Design, Endpoints, Protocol Development

NDA/BLA medical review of safety & efficacy, CMC review, pharmacology review

Clinical Operations Management (CRO & Vendor Selection, Contracting & Management)

Commercial Clinical Development and Strategy implementation.

FDA, NMPA, EMA, PMDA, and other regulatory interactions.

Vendor/CRO, Site, investigator selection, bid defense, and contracting.

Preclinical translational development support PIND/IND

PIND/IND medical, regulatory, quality review & applications, meetings

CMC Safety Assessments

ICH GCP Compliance assessments & training

Form external expert team to work with in-house team CEO/R&D

Due diligence for financing, valuation, acquisition, mergers & licensing