Regulatory Strategy & IND/IMPD Road-mapping
We chart a right-first-time regulatory path by aligning your data with FDA,…
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Preclinical Study Design & CRO Matchmaking
We design fit-for-purpose preclinical studies and identify the right GLP/AAALAC-compliant CROs to…
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GLP Toxicology & Safety Pharmacology
We coordinate GLP-compliant toxicology and safety pharmacology studies that regulators trust.
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DMPK/ADME & Bioanalytics
We develop and validate robust ADME and bioanalytical strategies that deliver reproducible,…
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Chemistry, Manufacturing & Controls
We build scalable, compliant manufacturing processes and seamless tech transfers ready for…
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Biologics & Vaccines (incl. NHP/Large Animal)
We design ethically justified biologic and vaccine studies, ensuring species relevance, immunogenicity…
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Medical Devices & Diagnostics
We guide biocompatibility, bench, and preclinical validation programs aligned with IEC 10993,…
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Program & Quality Oversight
We deliver independent GxP oversight, data-integrity reviews, and risk-based monitoring to keep…
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