Consultancy

Core Sector Expertise

• Regulatory StrategyFDA, EMA and global agency alignment
• Business DevelopmentPartnering, strategy and market positioning
• Grant Creation & SubmissionSBIR/STTR, NIH and foundation funding
• IND ApplicationsPreparation, assembly and pre-IND meetings
• API FormulationActive pharmaceutical ingredient development
• Computational ToxicologyIn silico safety prediction and modeling
• Risk Reduction PathwaysDe-risking development plans and milestones
• GLP Study DesignsGood Laboratory Practice preclinical studies
• SI Due Diligence ReportsScientific and investment due diligence
• Phase Zero StudiesMicrodosing and exploratory IND trials
• International Patent ApplicationsPCT filings and global IP strategy
• Commercialization & License NegotiationLicensing terms, deal structure and exits
• Funding Expertise & EvaluationCapital strategy, valuation and investor readiness

Emerging & State-of-the-Art Expertise

• AI-Driven Drug DiscoveryGenerative chemistry, protein structure prediction and target identification
• Synthetic Biology & BiomanufacturingEngineered cell factories, gene circuits and scalable bioprocessing
• Gene EditingCRISPR, base and prime editing program strategy
• Cell & Gene TherapyCAR-T, in vivo delivery, AAV and CMC readiness
• RNA TherapeuticsmRNA, siRNA and antisense platforms with lipid nanoparticle delivery
• Targeted Protein DegradationMolecular glues, PROTACs and degrader design
• Antibody-Drug Conjugates & RadiopharmaceuticalsPayload, linker and isotope strategy
• New Approach Methodologies (NAMs)Organoids, organ-on-chip and in silico alternatives to animal testing
• Precision Medicine & BiomarkersCompanion diagnostics, multi-omics and patient enrichment
• Real-World Evidence & Decentralized TrialsDigital endpoints, adaptive designs and RWE submissions
• Quantum & Computational BiologyAdvanced simulation for molecular modeling
• AI/ML Medical Device & SaMD RegulationFDA software-as-a-medical-device and AI pathway guidance