Accutest is a leading provider of customized and complex Bioavailability and Bioequivalence studies with regulatory compliance and global acceptance.
Phase II–IV studies for small and large molecules, nutraceuticals, therapeutic equivalence and clinical endpoint trials.
Characterization, clinical comparability (PK/PD), and immunogenicity studies for biosimilar products.
Claims databases, EHR curation, registry data analysis, HEOR, epidemiology, safety detection, and real-world evidence analytics.
Accutest is a leading provider of customized and complex Bioavailability and Bioequivalence (BA/BE) studies, trusted by global pharmaceutical companies for accuracy, compliance, and scientific excellence. As the Best CRO in India for complex bioequivalence studies, we bring deep therapeutic expertise and proven capability across a wide range of challenging study designs.With extensive experience in supporting submissions to highly regulated markets, Accutest is widely recognized as the Best CRO for bioequivalence studies for USFDA requirements, consistently delivering data that meets stringent global regulatory expectations.
Accutest’s commitment to quality, innovation, and end to end support makes us a preferred CRO partner for sponsors seeking precision driven, regulatory ready BA/BE results.
contact usDelivering world-class bioanalytical excellence with precision, compliance, and innovation.
Our lab delivers data-driven insights that help protect natural ecosystems and ensure regulatory excellence.
Ensuring comfortable, safe accommodation for large volunteer groups.
Trusted expertise in conducting high quality BA/BE studies at scale.
Certified and approved by major international regulatory authorities.
Strong volunteer network supporting diverse clinical programs.
Globally compliant, fully validated methods for accurate bioanalytical results.
Advanced LC MS/MS technology ensuring precise detection across diverse matrices.
Comprehensive solutions across complex dosage forms and specialized subject groups.
Fast/Fed/Sprinkled applesauce.
Fast/Fed BA/BE studies for controlled psychotropic substances
(e.g. depot injections/endogenous substances/diet restricted/teratogenic drugs)
Accutest has an exceptional BA/BE regulatory track record, with approvals and inspections from DCGI,MHRA,USFDA, EMA, WHO, ANVISA, DCGI, NPRA, and several other global authorities ensuring that data generated withstands the scrutiny of major markets worldwide.
Accutest’s bioanalytical team has deep expertise in developing and validating complex assays, especially those requiring simultaneous quantification of multiple analytes and metabolites within a single analytical run. These capabilities demonstrate our scientific strength, method development maturity, and ability to support challenging regulatory submissions.
These studies require:
Accutest’s bioanalytical team possesses specialized expertise in the analysis of chiral molecules, enantiomers, and positional isomers an area that requires advanced chromatographic techniques, precise method development, and deep scientific understanding. Chiral separation is often a regulatory requirement for many drugs, given that enantiomers can differ significantly in pharmacokinetics and pharmacodynamics. Our laboratory has successfully executed chiral LC MS/MS assays across a wide range of therapeutic areas.
| Drug / Analytes | Therapeutic Category |
|---|---|
| R and S Ibuprofen | NSAID |
| R and S Bicalutamide | Anticancer |
| R and S Warfarin | Anticoagulant |
| R and S Linezolid | Antibacterial |
| Eu and Zu Clomifene | Gonad-stimulating hormone |
Our team excels in addressing complex challenges such as:
This expertise ensures that sponsors receive high quality, defensible data for regulatory filings in global markets.
Comprehensive clinical & regulatory solutions
SITES Inspected
Therapeutic Areas
Phase II Studies
Phase III / IV
PK Studies
Milestones & Inspection Records
Regulatory Agency - - USFDA
Location -
Ahmedabad
Therapeutic area - Psychiatry
Inspection
Timing - July 2012
Regulatory Agency - USFDA
Location - Surat
Therapeutic area - Psychiatry
Sep 2015
Regulatory Agency - USFDA
Location - Junagadh
Therapeutic area - Psychiatry
Apr 2015
Regulatory Agency - USFDA
Location -
Ahmedabad
Therapeutic area - Psychiatry
Jun 2018
Regulatory Agency - USFDA
Location -
Vijayawada
Therapeutic area - Oncology
Oct 2018
Regulatory Agency - USFDA
Location -
Surat
Therapeutic area - Oncology
Dec 2018
Regulatory Agency - USFDA
Location -
Vadodara
Therapeutic area - Oncology
Jan 2019
Regulatory Agency - USFDA
Location -
Bengaluru
Therapeutic area - Oncology
Jan 2020
Regulatory Agency - USFDA
Location - Nadu
Therapeutic area - Oncology
Feb 2020
Regulatory Agency - NPRA
Location -
Junagadh
Therapeutic area - GPsychiatry
Mar 2023
Regulatory Agency - USFDA
Location -
Ahmedabad
Therapeutic area-Psychiatry
Inspection
Timing-July 2012
Regulatory Agency - USFDA
Location - Surat
Therapeutic area - Psychiatry
Sep 2015
Regulatory Agency - - USFDA
Location - Junagadh
Therapeutic area - Psychiatry
Apr 2015
Regulatory Agency - - USFDA
Location -
Ahmedabad
Therapeutic area - Psychiatry
Jun 2018
Regulatory Agency - USFDA
Location -
Vijayawada
Therapeutic area - Oncology
Oct 2018
Regulatory Agency - USFDA
Location -
Surat
Therapeutic area - Oncology
Dec 2018
Regulatory Agency - USFDA
Location -
Vadodara
Therapeutic area - Oncology
Jan 2019
Regulatory Agency - USFDA
Location -
Bengaluru
Therapeutic area - Oncology
Jan 2020
Regulatory Agency - USFDA
Location - Nadu
Therapeutic area - Oncology
Feb 2020
Regulatory Agency - NPRA
Location -
Junagadh
Therapeutic area - GPsychiatry
Mar 2023
Recognized by Leading International Authorities
Comprehensive bioanalytical testing, biosimilar analysis, and clinical lab services powered by expert scientists, robust quality systems, and advanced biologics capabilities.