Services
Disciplined execution from Hyderabad—with strategic partners widening the aperture on preclinical, late bioanalysis corridors, vigilant PV and dossier authoring when molecules demand distributed expertise.
Through our strategic partners across the globe, we extend our reach into preclinical work, early- to late-phase bioanalysis (LC‑MS), regulatory support, pharmacovigilance and medical writing. All collaborative laboratories are US FDA approved.
Equivalence and relative bioavailability with submission-aligned statistics. CRBio has 1000+ BA/BE studies completed and submitted across major regulatory bodies, including US FDA, MHRA, EMA, WHO, Health Canada, CDSCO and other national authorities.
Patient-based PK/PD endpoints—including programmes on azathioprine, nevirapine, temozolomide, clozapine & capecitabine—with populations spanning post‑menopause, hormonal therapy, patches, controlled/psychotropic actives; PD experience (e.g. Orlistat), 505(b)(2), first‑to‑file, and ethically supervised escalation with ICU readiness.
Model-ready summaries, exploratory statistics and programme consulting grounded in multinational filing expectations—from first‑in‑human extrapolation through abbreviated filings, first‑to‑file strategies and intricate chiral quantitation narratives.
EDC builds, discrepancy resolution and inspection-conscious datasets tethered to simultaneous clinical and analytical progress. Time is critical in clinical research—we commit to disciplined quality within agreed timelines.
LC‑MS tandem HPLC choreography, nuanced sample custody and assays across 300+ validated methods—simple to simultaneous assays, stringent LLOQ work, chiral & derivatisation motifs, controlled substances and speciality matrices. Eight −86 °C chambers monitored round-the-clock via Eurotherm · 21 CFR Part 11 surveillance. We emphasise high throughput analytics with aggressive turnaround for unconventional chemistries.
Preclinical amplification, geographically distributed LC‑MS, regulatory dossier assembly support, vigilant pharmacovigilance stewardship and medically authored dossier narratives. Collaborative laboratories are uniformly US FDA approved—giving sponsors flexibility without diluting Hyderabad accountability during transfers.
