Accutest Research Laboratories - A Trusted Indian CRO

Bioequivalence Studies (BA/BE)

Accutest is a leading provider of customized and complex Bioavailability and Bioequivalence (BA/BE) studies. With deep therapeutic experience and a wide range of study designs, we deliver reliable, regulatory-compliant outcomes tailored to sponsor needs — ensuring accuracy, subject safety, and global acceptance.

Late Phase(Phase II-IV)

Phase II to IV studies for small/large molecules, PMS, Nutraceuticals, therapeutic equivalence, clinical end point

Biologics

Characterization, Clinical comparability (PK / PD, studies), Immunogenicity studies for Biosimilar products

CDM & Biostatistics & Real World Evidence

Data sources Claims databases EHR data curation Registry data analysis Market access datasets Analytics Retrospective cohort studies Treatment pattern analysis Comparative effectiveness studies Safety signal detection Epidemiology studies HEOR deliverables Budget impact models Cost-effectiveness analysis Outcomes research reports Publications & congress abstracts

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

Our scientific and operational teams specialize in first-to-file generic drug BA/BE studies, offering tailored solutions that accelerate development timelines while ensuring subject safety, protocol compliance, and reliable study outcomes.

Collaborative Approach

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.

BA/BE Capabilities at a Glance/Why Partner with Accutest

98%

Environmental Science

Our lab delivers data-driven insights that help protect natural.

262+ Clinical Beds

Ensuring comfortable, safe accommodation for large volunteer groups.

3500+ BA/BE Studies Completed

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

140+ Regulatory Accreditations

Certified and approved by major international regulatory authorities.

45,000+ Healthy Volunteer Database

We work closely with academic institutions, private industries, and government agencies to co-develop innovative research.

1000+ Validated Analytical Methods

Globally compliant, fully validated methods for accurate bioanalytical results.

21 or 21 LC–MS/MS Systems

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

Expertise in Challenging Clinical Studies

Accutest is recognized for its ability to manage high-risk and medically sensitive BA/BE programs while upholding the highest standards of subject protection.Handling Drugs with Critical Safety Risks
Potassium Chloride/Citrate (Electrolyte Replenisher)
Key Challenge: Risk of cardiac arrhythmia
Experience: 11 studies completed
Buprenorphine (Opioid Analgesic)
Key Challenge: Cardio-respiratory depression
Experience: 3 studies completed
Cinacalcet (Calcimimetic)
Key Challenge: High incidence of emesis
Experience: 11 studies completed
Our clinical teams are trained to anticipate, mitigate, and manage such risks with robust medical oversight and protocol-driven safety controls.

Expertise in Specialized Populations

Conducting BA/BE studies in specialized populations demands scientific precision and operational rigor. These studies often involve: Variability in physiology and drug metabolism Limited subject pools and strict inclusion/exclusion criteria Complex dosing considerations Tailored study designs for population-specific kinetics Accutest collaborates closely with medical experts and ethics committees to ensure scientifically sound, ethical, and safe execution of such studies.

Expertise in Endogenous Substances

Endogenous molecules present unique analytical and clinical complexities. Accutest has successfully executed large-scale studies, including: Vitamin K Injection – 100 subjects Growth Hormone Injection – 40 subjects Our expertise covers: Baseline correction and differentiation of endogenous vs. exogenous levels Sensitive, specific assay development Managing inter-individual variability Designing protocols that meet regulatory expectations for endogenous compounds

Expertise in Complex Drugs

Extended-release formulations, combination products, and modified-release systems require advanced scientific approaches. Our teams excel in: Characterizing complex release mechanisms Developing specialized analytical methods Designing study protocols aligned with global guidance Advanced PK modeling and robust statistical analyses We work closely with regulators and scientific bodies to ensure defensible bioequivalence outcomes for complex generics.

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.

Drug / Analytes	Complexity	Therapeutic Category
Bupropion and its Hydroxy, Erythro, and Threo metabolites (4 analytes)	High-complexity metabolic profiling	Antidepressant
Atorvastatin and its Ortho and Para metabolites (3 analytes)	Simultaneous measurement of parent + multiple isomers	Antilipemic
Sibutramine and its Desmethyl & Didesmethyl metabolites (3 analytes)	Multi-metabolite quantification with stability challenges	Anti-obesity
Dolutegravir, Emtricitabine and Tenofovir Alafenamide	Multi-analyte quantification	Antiretroviral drugs
Valsartan, Sacubitril and Sacubitril Metabolite LBQ657	Multi-analyte quantification	Angiotensin Receptor–Neprilysin Inhibitor (ARNI)

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.

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:

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.

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.

Late Phase( Phase-II - IV trials)

Accutest provides Phase II–IV clinical development across key therapeutic areas.

Accutest offers comprehensive Phase II to Phase IV clinical development services for both small and large molecules, covering a broad spectrum of therapeutic areas such as oncology, cardiovascular, psychiatry, neurology, dermatology, infectious diseases, and more. Our expertise also includes post-marketing surveillance (PMS) studies and specialized research involving nutraceuticals. Supported by a highly experienced clinical operations team and a strong investigator network, Accutest is recognized as a CRO with trained clinical research coordinators who ensure smooth site management, protocol adherence, and high-quality data collection. As a CRO with access to large patient populations, we enable faster recruitment, operational efficiency, and timely study execution across diverse therapeutic categories. With robust quality systems, scientific rigor, and an unwavering focus on patient safety, Accutest consistently delivers accurate data and reliable clinical outcomes. Our commitment to excellence ensures that sponsors receive dependable results that support successful regulatory submissions and expedite market approvals.

Our Service

Clinical Operations

Site Management

Regulatory Documentation and Submission Support

Project Management

Data Management

Biostatistics & Programming

Medical Writing

Medical Monitoring

Medical Affairs

Quality Assurance

Pharma Covigilance