Cliantha’s small molecule lab services integrate state-of-the-art technologies with deep scientific expertise to support complex method development, validation, and sample analysis.
With over 21 years of experience, Cliantha has enabled the successful advancement of thousands of compounds by leveraging advanced analytical platforms and applying validated assays across all phases of drug development.
A comprehensive suite of regulated bioanalytical services is offered through facilities in Ahmedabad, India, and Toronto, Canada—available as standalone engagements or as fully integrated service packages.
Backed by a strong portfolio of 950+ validated methods, high-sensitivity assays are delivered with low pg/mL quantification and robust lower limits of quantification (LLOQ), utilizing stable isotope internal standards to ensure accuracy and reproducibility. Expertise spans full validation and sample analysis in plasma, serum, and urine, supporting First-in-Human (FIH), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies with precision and regulatory compliance.
Method Development
At Cliantha analytical method development involves critical thinking at its initial stage. which starts with assessing drug attributes like concentration, purity, and physical properties of the drug. where the optimization of analytical technique is based on a methodical and research-driven approach. We incorporate tailored experimental conditions, sensitive instruments, and detection methods. Our robust methods are sensitive, specific, robust and reliable, ensuring consistency and compliance for your applications.
Our portfolio in Method development
Hormones
▼Developing bioanalytical methods for hormones presents distinct challenges due to the unique chemical properties of hormones, low physiological concentrations, possible Endogenous presences and complex biological matrices, with advanced instrumentation and experienced team to address these issues and deliver reliable, sensitive, and accurate data for clinical trials.
Inhalation Formulation
▼Our team of bio scientists ensures sensitive assays up to 0.200 pg/mL be available for inhaled formulations to achieve accurate and reproducible quantification of the drug in biological samples, including optimizing extraction, addressing matrix effects, and ensuring stability of the analyte.
Elemental Bioanalysis
▼Our team provides advanced elemental bioanalysis for clinical research, specializing in the accurate and sensitive measurement of trace elements, metals, and their species in biological matrices. Ensuring the safety and quality of your pharmaceutical products with our elemental bioanalysis services. We accurately measure trace metals and elemental impurities in complex biological samples, providing high-sensitivity and high-throughput data using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). We help you meet stringent regulatory requirements with confidence.
Chiral Molecules
▼For molecules exhibiting isomerism, Isomers have a major role to understand the pharmacological activity and any adverse effect. Our seasoned professional ensures that the complexity of high efficiency enantioselectivity separation with the selected sample matrix have reproducibility and resolution with high throughput.
Endogenous Molecules
▼Our expertise includes the sensitive and accurate quantification of endogenous compounds, such as hormones and biomarkers, in complex biological matrices. We offer robust, validated methods to differentiate your therapeutic from naturally occurring substances, providing the high-quality data required for your clinical and preclinical studies.
NCE’s
▼Accelerate your NCE development with our team of bioanalysis experts, we add value to your New Chemical Entity (NCE) development with over 20 years of bioanalysis expertise. Our seamless analytical support and advanced SCIEX 7500 equipment provide dependable results through every phase of clinical trials.
Steroids
▼we offer high-sensitivity mass spectrometry for the accurate and reliable quantification of steroid hormones in various biological matrices. Our validated methods address the unique challenges of analyzing steroids, such as differentiating between endogenous and exogenous compounds to support your clinical and preclinical studies.
Complex Generics
▼Successfully developing complex generics is a regulatory challenge. We provide strategic method development and bioanalytical testing to help you meet stringent requirements from global regulatory bodies, including the FDA and EMA. We specialize in:
- Establishing bioequivalence using advanced analytical technologies and modeling.
- Addressing variability in physicochemical and structural characteristics.
- Navigating different regulatory pathways, including 505(j) and 505(b)(2).
Trust our expertise to ensure your complex generic submissions are robust and compliant.
Method Validation
Our focus is validating analytical methods to guarantee they meet rigorous performance criteria and global regulatory standards. We ensure regulatory compliance by thoroughly validating analytical methods against predefined performance criteria.
We conduct comprehensive assessments of critical parameters, including the Limit of Quantitation (LOQ), linearity, and system suitability, ensuring full compliance with global regulatory guidelines. The validated methods provided are designed to yield consistent, reproducible, and actionable data of high integrity.
Sample analysis
Our bioanalytical lab specializes in advanced sample analysis across a variety of biological matrices, including blood, plasma, and urine.
We perform precise and advanced sample analysis, converting complex samples into valuable data. Our state-of-the-art bioanalytical lab is equipped to support your pharmacokinetic (PK), pharmacodynamic (PD), toxicology, and efficacy evaluations by accurately determining substance presence, concentration, and characteristics.
Precision research enabled by state-of-the-art bioanalytical infrastructure
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✓ LC-MS/MS
- 55 LC/MS/MS (API 4000, API 6500+, API 5500,API 4500, Sciex 7500, Shimadzu 8060NX equipped with UFLC & HPLCs)
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✓ ICP-MS
- Thermo Scientific iCAP-RQ
Sample Storage Capacity
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✓ Deep freezers at -20˚C and -70˚C
- 1.6 million sample storage capacity at -20°C
- 1.2 million sample storage capacity at -70°C
Biorepository
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✓ Deep freezers at -20˚C and -70˚C
- 1.6 million sample storage capacity at -20°C
- 1.5 million sample storage capacity at -70°C
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✓ 8 LC-MS/MS systems
- 6 API 4000 and 2 API 6500.
- Modern Sample Processing Laboratory having Independent Light Sensitive sample processing area
- Data acquisition with audit trail system
- ✓ 2 independent clinical units
- ✓ 60 bed capacity & 6 bed ICU
- ✓ 1 temperature/humidity-controlled room
- ✓ 3 Specialized Environmental Rooms for Allergy, Dry Eye and Pollutants
- ✓ On-Site Pharmacy with control substance license Level 5
Our Large Molecule Laboratory provides end-to-end bioanalytical services to support biologics, biosimilars, hormones, peptides, proteins, and vaccines, from early discovery through late‑stage clinical development. With more than 15 years of hands‑on experience across diverse molecule types, we deliver scientifically rigorous, regulator‑ready data that enables confident development decisions.
At Cliantha, we follow established industry best practices and global regulatory guidelines to ensure high‑quality, reliable outcomes. Each year, our team processes more than one lakh bioanalytical samples, supporting studies across biosimilars, pharmacokinetics (PK), immunogenicity (including anti‑drug antibody assessments), and neutralizing antibody assays.
Advanced Technology. Extensive Molecule Experience
Our expanding large molecule service portfolio is powered by a wide range of validated assays, enabling us
to address the evolving requirements of the pharmaceutical industry with precision and reliability
Our Capabilities
Cliantha Advantage
ROBUST, SENSITIVE, AND SCALABLE BIOANALYTICAL SOLUTIONS DRIVEN BY ADVANCED TECHNOLOGY AND DEEP SCIENTIFIC EXPERTISE.
- Pharmacokinetic (PK) Assays
- Immunogenicity Assays (ADA / Tiers 1–3)
- Neutralizing Antibody (NAb) Assays — Surrogate & Cell Based
- Cell Based Functional Assays
- Biomarker & Pharmacodynamic (PD) Assays
- Vaccine Immunogenicity & Potency Testing
- ELISA (Enzyme Linked Immunosorbent Assays)
- MSD / ECL (Electrochemiluminescent) Platforms
- Cell Based Assay Platforms (for NAb)
- Flow Cytometry (Immunophenotyping)
- Multiplex Cytokine / Biomarker Panels
- Fit for Purpose & Validated Method Platforms
- Assay Development, Qualification & Validation Expertise
- Biosimilar Focused Immunogenicity & NAb Workflows
- Assay Bridging & Comparability Support
- SulfoTag & Biotin Labeling Capabilities
- Advanced Immunogenicity Tools - Acid Dissociation • SPEAD • ACE • PandA
- Statistical Analysis for Cut Point Determination
- Achieving Competitive Timelines
- Scientific Consultation & Regulatory Aligned Documentation
