Designed as a vertically integrated facility — discovery, formulation, analytical, clinical operations and AI compute under one roof.
Biologics & BiosimilarsCell-line development, upstream/downstream process development, characterization and analytical comparability.
Formulation DevelopmentOral solids, injectables, specialty dosage forms and nutraceutical formulations across stability and scale-up programs.
Analytical & QC LabHPLC/UPLC, mass spectrometry, dissolution, microbiology and bio-assay capabilities under ISO 17025 alignment.
BE / BA StudiesBioequivalence and bioavailability studies aligned with FDA, EMA and WHO guidelines, executed via partner clinics.
Clinical OperationsPhase I–IV trial design, site management, monitoring and IND/NDA/ANDA submission support.
AI & Data SciencesAI-enabled trial design, pharmacovigilance signal detection, predictive analytics and drug discovery workflows.
Regulatory AffairsFDA, EMA and emerging-market submission readiness, life-cycle management and compliance training.
Functional Foods LabNutraceutical and functional-food product development, claim substantiation and stability programs.
Translational HubJoint programs with academic medical centres, hospitals and CROs across the NY/NJ region.