Catalyzing Innovation Hyderabad · Est. 2007
Delivering excellence. Building trust.
CRBio — A trusted partner delivering integrated BA/BE solutions with accountability, quality and scientific precision.
A division of Chromo laboratories India Private Limited.
Regulators & frameworks we align with
Regulatory submissions
1000+ BA/BE studies completed and submitted across major regulatory bodies, including US FDA, MHRA, EMA, WHO, Health Canada, CDSCO and other national authorities.
Marks are shown for context on programme geographies; ownership remains with each agency. Brochure-aligned artwork—swap for separately cleared assets if required.
Why CRBio
- An integrated, accountable team managing your study end-to-end
- State-of-the-art clinical and bioanalytical capabilities
- Expertise in PK analysis, biostatistics and data management
- Single-point accountability with transparent communication
- Quality, compliance and timely delivery backed by 19+ years of experience
Bioanalytics & storage
9 LC‑MS systems with HPLC routes; eight −86 °C freezers; Eurotherm 21 CFR Part 11 temperature governance.
Clinical capacity
4 independent clinical pharmacology units with 114‑bed unit; twin functional ICUs (3 beds each); male & female volunteer programmes; speciality populations & patient PK pathways.
Regulatory & dossier coherence
1000+ BA/BE studies completed and lodged with major regulators—programme leadership that respects inspection cadence.
Integrated offering
From molecule discussion to dossier-ready evidence
BA/BE dossiers
Equivalence & comparative bioavailability with submission-aligned statistics.
DetailsPatient PK/PD & trials
Endpoint studies—including named patient programmes—with ICU-ready escalation.
DetailsPK & statistics
Modelling-ready outputs, exploratory stats, abbreviated pathway counselling.
DetailsData management
EDC-aligned capture, discrepancy paths and inspection-aware datasets.
DetailsBioanalysis (India labs)
LC‑MS; 300+ validated methods incl. chiral & LLOQ-demanding assays.
DetailsPartner-augmented reach
Preclinical depth, global bioanalysis corridors, PV & medical writing—US FDA-approved collaborators.
Details
Throughput without compromising traceability
Clinical research timelines are relentless—we organise sample logistics, QA touchpoints and documentation so exploratory science still meets filing discipline.
Capability
Our strength and expertise
We assure high-throughput sample analysis and quick turnaround times for challenging molecules. Our team blends young energy with deep domain expertise and regulatory judgement.
The library now spans 300+ validated methods—from simple and simultaneous assays through ultra-low LLOQ work, chiral and derivatisation strategies, and speciality matrices.
Experience footprint
- Studies on controlled substances
- Psychotropic substances
- Post-menopausal female cohorts
- Hormonal drugs
- Patch studies
- 505(b)(2) pathway
- First-to-file experience
- PD study experience (Orlistat)
- PK endpoint studies — azathioprine, nevirapine, temozolomide, clozapine, capecitabine
Next step
Route your brief to BD or programmes
Postal address and telephone are listed on our Contact page and in the site footer. For a quick route in, email info@crbio.co.in.