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Capabilities

Bioequivalence Studies (BA/BE)

Accutest is a leading provider of customized and complex Bioavailability and Bioequivalence studies with regulatory compliance and global acceptance.

Late Phase (Phase II IV)

Phase II–IV studies for small and large molecules, nutraceuticals, therapeutic equivalence and clinical endpoint trials.

Biologics

Characterization, clinical comparability (PK/PD), and immunogenicity studies for biosimilar products.

CDM, Biostatistics & RWE

Claims databases, EHR curation, registry data analysis, HEOR, epidemiology, safety detection, and real-world evidence analytics.

BA/BE Services

India’s Leading CRO for Complex
BA/BE Studies

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.

Proven Track Record

Regulatory Excellence

Choosing Us for Clinical Excellence

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.

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BA/BE Capabilities at a Glance
Why Partner with Accutest

Delivering world-class bioanalytical excellence with precision, compliance, and innovation.

98%

Environmental Science

Our lab delivers data-driven insights that help protect natural ecosystems and ensure regulatory excellence.

262+ Clinical Beds

Ensuring comfortable, safe accommodation for large volunteer groups.

3500+ BA/BE Studies Completed

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Trusted expertise in conducting high quality BA/BE studies at scale.

140+ Regulatory Accreditations

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Certified and approved by major international regulatory authorities.

45,000+ Healthy Volunteer Database

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Strong volunteer network supporting diverse clinical programs.

1000 + Validated Analytical Methods

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Globally compliant, fully validated methods for accurate bioanalytical results.

21 LC MS/MS Systems

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Advanced LC MS/MS technology ensuring precise detection across diverse matrices.

Accutest Expertise In Various Dosage

Comprehensive solutions across complex dosage forms and specialized subject groups.

Single dose BA/BE studies

Fast/Fed/Sprinkled applesauce.

Multiple doses BA/BE studies

Fast/Fed BA/BE studies for controlled psychotropic substances

Partial/full replicate/switch ability design studies Injectable

Long housing studies

(e.g. depot injections/endogenous substances/diet restricted/teratogenic drugs)

Suppositories / Enema

Vaginal route specific dosage

Post menopausal female subjects

Geriatric subjects

Food effect studies

Hypo gonadal male subjects

Bioanalytical Laboratory & Team

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.

1. Expertise in Simultaneous Multi Analyte/ Metabolites +

These studies require:

  • Highly selective chromatographic methods
  • Robust extraction procedures to maintain recovery Analytes and metabolites
  • Stability controlled sample preparation
  • Sensitive and specific mass transitions for each Analyte/metabolites
  • Rigorous validation as per global regulatory expectations (EMA, FDA, ANVISA, WHO, Canada)
  • Our ability to perform such specialized assays highlights our analytical maturity and proficiency in supporting complex BA/BE and clinical programs.
2. Expertise in Enantiomer & Positional Isomer Analysis ×

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
3. Our Strength in Chiral Methodology +

Our team excels in addressing complex challenges such as:

  • Development of robust chiral chromatographic methods
  • Separation of closely related isomers with minimal interference
  • Accurate quantification of each enantiomer under stringent sensitivity requirements
  • Ensuring stability and reproducibility across long analytical runs
  • Compliance with global regulatory expectations for chiral drugs
  • Managing shifts in enantiomer interconversion or degradation

This expertise ensures that sponsors receive high quality, defensible data for regulatory filings in global markets.

4. Why Sponsors Choose Accutest +
  • Deep expertise in multi analyte and multi metabolite quantification
  • Proven success across the most challenging therapeutic classes
  • Large scientific team with decades of method development experience
  • High throughput operations that safeguard project timelines
  • Reliable, reproducible data that withstand global regulatory scrutiny
  • Your Trusted Partner for Complex Bioanalysis

    Accutest delivers high quality bioanalytical solutions for even the most demanding studies helping sponsors accelerate approvals while maintaining scientific excellence.

BA/BE Services in Numbers

Delivering excellence with scale, precision and regulatory compliance

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Clinic Beds

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Studies

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Regulatory Accreditations

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Volunteer Database

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Methods

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LC MS/MS Machines

Late Phase (Phase II – IV Trials)

Accutest offers comprehensive Phase II to Phase IV clinical development services across multiple therapeutic areas.
  • Comprehensive Phase II to Phase IV clinical development services
  • Expertise in both small molecules and large molecules
  • Therapeutic expertise in Oncology, Cardiovascular, Psychiatry, Neurology, Dermatology, and Infectious Diseases
  • Post Marketing Surveillance (PMS) studies
  • Specialized research in nutraceuticals
  • Highly experienced clinical operations team
  • Strong investigator network with trained Clinical Research Coordinators (CRCs)
  • Efficient site management and strict protocol adherence
  • High-quality and accurate data collection
  • Access to large patient populations for faster recruitment
  • Operational efficiency and timely study execution
  • Robust quality systems with strong regulatory compliance
  • Strong focus on patient safety and scientific rigor
  • Reliable data supporting regulatory submissions and faster market approvals

Our Services

Comprehensive clinical & regulatory solutions

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SITES Inspected

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Therapeutic Areas

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Phase II Studies

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Phase III / IV

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PK Studies

Regulatory Inspection History

Milestones & Inspection Records

2012

Regulatory Agency - - USFDA
Location - Ahmedabad
Therapeutic area - Psychiatry
Inspection Timing - July 2012

2015

Regulatory Agency - USFDA
Location - Surat
Therapeutic area - Psychiatry
Sep 2015

2015

Regulatory Agency - USFDA
Location - Junagadh
Therapeutic area - Psychiatry
Apr 2015

2018

Regulatory Agency - USFDA
Location - Ahmedabad
Therapeutic area - Psychiatry
Jun 2018

2018

Regulatory Agency - USFDA
Location - Vijayawada
Therapeutic area - Oncology
Oct 2018

2018

Regulatory Agency - USFDA
Location - Surat
Therapeutic area - Oncology
Dec 2018

2019

Regulatory Agency - USFDA
Location - Vadodara
Therapeutic area - Oncology
Jan 2019

2020

Regulatory Agency - USFDA
Location - Bengaluru
Therapeutic area - Oncology
Jan 2020

2020

Regulatory Agency - USFDA
Location - Nadu
Therapeutic area - Oncology
Feb 2020

2023

Regulatory Agency - NPRA
Location - Junagadh
Therapeutic area - GPsychiatry
Mar 2023

2012

Regulatory Agency - USFDA
Location - Ahmedabad
Therapeutic area-Psychiatry
Inspection Timing-July 2012

2015

🎯

Regulatory Agency - USFDA
Location - Surat
Therapeutic area - Psychiatry
Sep 2015

2015

🔍

Regulatory Agency - - USFDA
Location - Junagadh
Therapeutic area - Psychiatry
Apr 2015

2018

💎

Regulatory Agency - - USFDA
Location - Ahmedabad
Therapeutic area - Psychiatry
Jun 2018

2018

Regulatory Agency - USFDA
Location - Vijayawada
Therapeutic area - Oncology
Oct 2018

2018

Regulatory Agency - USFDA
Location - Surat
Therapeutic area - Oncology
Dec 2018

2019

Regulatory Agency - USFDA
Location - Vadodara
Therapeutic area - Oncology
Jan 2019

2020

Regulatory Agency - USFDA
Location - Bengaluru
Therapeutic area - Oncology
Jan 2020

2020

Regulatory Agency - USFDA
Location - Nadu
Therapeutic area - Oncology
Feb 2020

2023

Regulatory Agency - NPRA
Location - Junagadh
Therapeutic area - GPsychiatry
Mar 2023

Global Regulatory Approvals & Certifications

Recognized by Leading International Authorities

FDA WHO ANVISA MHRA AGES ANSM CESO AEMPS Turkey MOH MCC South Africa Thailand Health NABL DEA
Biologics

Advancing Global Drug Development with Trusted Biologics Expertise

Comprehensive bioanalytical testing, biosimilar analysis, and clinical lab services powered by expert scientists, robust quality systems, and advanced biologics capabilities.

Accutest’s Biologics division brings specialized scientific expertise and advanced analytical capabilities to support end to end biologics and biosimilar development. Our strengths span several critical domains essential for establishing product quality, safety, and comparability.
Advanced cellular and molecular techniques enabling precise characterization of complex biologics.
Our immunology capabilities include a wide range of assays essential for biologics, biosimilars, and vaccine programs supporting immune response evaluation, safety assessment, and regulatory submissions.
We specialize in laboratory testing, analytical research, scientific custom experiments and data interpretation.
We offer validated assays for Anti Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) to evaluate immunogenicity risks, patient safety, and clinical relevance throughout the development lifecycle.