CDSCO Approved · NABL Accredited Lab

Clinical Trials & Bioanalytical Testing Laboratory India

Auriga Research operates an integrated clinical trial and bioanalytical testing facility in India, combining GCP-compliant clinical operations with NABL-accredited analytical laboratories. Our capabilities span Phase I-III pharmaceutical clinical trials, bioequivalence and pharmacokinetic studies, and specialised cosmetic and personal care clinical research.

Our bioanalytical laboratory is equipped with multiple LC-MS/MS systems, HPLC-UV platforms, and immunoassay capabilities validated per FDA Bioanalytical Method Validation Guidance (2018). We handle plasma, serum, urine, and tissue matrices for small-molecule and large-molecule analytes across all major therapeutic areas.

For the cosmetics and personal care industry, we conduct HRIPT testing (Human Repeat Insult Patch Test), SPF in-vivo testing per ISO 24444, and cosmetic efficacy clinical studies covering anti-ageing, moisturisation, skin brightening, hair care, and dermal safety. These clinical studies are conducted under dermatologist supervision with Ethics Committee approval and generate data accepted by CDSCO, EU regulators, and major retail buyers.

Request a Study Proposal Call +91-7428116100

Cosmetic & Personal Care Clinical Studies

These are the highest-value clinical services for cosmetic and personal care brands — essential for regulatory compliance, retail buyer requirements, and marketing claims substantiation.

HRIPT Testing

Human Repeat Insult Patch Test — the definitive method for assessing allergic contact sensitisation potential. Required by most regulatory bodies and major retailers before product launch.

50-200 subject panels
Dermatologist-supervised
CTFA/PCPC protocol compliance
9-week standard study duration

SPF In-Vivo Testing

Sun Protection Factor determination on human subjects per ISO 24444 methodology. The only method accepted for SPF label claims in most global markets.

ISO 24444 compliant
Calibrated UV sources
Trained MED assessors
Statistical validation per ISO

Cosmetic Efficacy Studies

Instrumental and clinical assessment studies that substantiate marketing claims with objective, reproducible data accepted by regulators and advertising standards bodies.

Anti-ageing and wrinkle reduction
Moisturisation (Corneometer)
Skin brightening (Chromameter)
Hair growth and anti-dandruff

Pharmaceutical Clinical Trials

Our pharmaceutical clinical trial operations cover the full development lifecycle from first-in-human Phase I studies through large-scale Phase III pivotal trials. We manage protocol design, regulatory submissions to CDSCO, Ethics Committee approvals, CTRI registration, site management, patient recruitment, monitoring, data management, biostatistical analysis, and clinical study report preparation per ICH E3.

Bioequivalence and pharmacokinetic studies are conducted in our dedicated clinical pharmacology unit with 24-hour medical supervision, emergency resuscitation facilities, and on-site bioanalytical sample processing. Study designs follow CDSCO guidelines for BA/BE studies and FDA guidance on bioequivalence study design for immediate-release and modified-release formulations.

Phase I Studies

✓ First-in-human dose escalation
✓ Single ascending dose (SAD)
✓ Multiple ascending dose (MAD)
✓ Food effect studies
✓ Bioequivalence studies

Phase II & III Studies

✓ Dose-finding and dose-response
✓ Pivotal efficacy trials
✓ Multi-centre study management
✓ Adaptive trial designs
✓ Oncology, cardiology, dermatology

Bioanalytical Laboratory Capabilities

Our NABL-accredited bioanalytical laboratory operates under Good Laboratory Practice principles with validated analytical methods for pharmacokinetic sample analysis. Method development and validation follow FDA Bioanalytical Method Validation Guidance (2018) and EMA Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/192217/2009 Rev.1).

Instrumentation includes multiple triple-quadrupole LC-MS/MS systems, UHPLC platforms, GC-MS, and immunoassay (ELISA) capabilities. We process plasma, serum, whole blood, urine, and tissue homogenate samples with validated extraction procedures (protein precipitation, liquid-liquid extraction, solid-phase extraction). All systems operate under 21 CFR Part 11 compliant data management with full audit trails.

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Frequently Asked Questions

What is HRIPT testing and why is it important for cosmetics?

HRIPT (Human Repeat Insult Patch Test) is the gold standard clinical study for assessing allergic contact sensitisation potential of cosmetic and personal care products. A panel of human subjects is exposed to the test product over multiple applications (induction phase) followed by a rest period and challenge application. HRIPT data is required by regulatory authorities and major retailers before product launch. Auriga Research conducts HRIPT studies under dermatologist supervision with panel sizes per CTFA/PCPC guidelines, typically 50-200 subjects.

How does SPF in-vivo testing work?

SPF (Sun Protection Factor) in-vivo testing measures the actual sun protection efficacy of sunscreen products on human skin per ISO 24444 methodology. Controlled UV radiation is applied to treated and untreated skin sites on volunteer panels, and the minimal erythemal dose (MED) is measured. The SPF value is calculated as the ratio of MED on protected versus unprotected skin. Auriga Research conducts SPF testing with calibrated UV sources, trained assessors, and panel sizes meeting ISO 24444 statistical requirements.

What bioanalytical methods does Auriga Research use?

Our bioanalytical laboratory employs validated LC-MS/MS (liquid chromatography-tandem mass spectrometry) methods for pharmacokinetic sample analysis. We also use HPLC-UV, GC-MS, immunoassays (ELISA), and ligand binding assays depending on the analyte and matrix. Method validation follows FDA Bioanalytical Method Validation Guidance (2018) and EMA guidelines, covering selectivity, calibration curve, accuracy, precision, matrix effect, recovery, and incurred sample reanalysis (ISR). All methods are validated before study sample analysis begins.

What is the typical timeline for a clinical trial in India?

Timelines vary by study phase and complexity. A bioequivalence study typically takes 4-6 months from protocol finalisation to clinical study report. Phase II studies run 12-18 months, and Phase III pivotal trials may take 18-36 months. CDSCO regulatory approval typically takes 4-8 weeks for bioequivalence studies and 8-12 weeks for new drug clinical trial applications. Auriga Research provides detailed Gantt charts and milestone timelines during the proposal stage.

Does Auriga Research conduct cosmetic efficacy clinical studies?

Yes. Our clinical research division conducts a full range of cosmetic efficacy studies including anti-ageing (wrinkle reduction), moisturisation (corneometry), skin brightening (chromameter), hair growth, anti-dandruff, and dermal tolerance. These studies use instrumental measurements (Cutometer, Corneometer, TEWL meter, Mexameter) combined with clinical grading by dermatologists and subject self-assessment questionnaires. Study designs follow ICMR guidelines and are reviewed by independent Ethics Committees.

Get a Clinical Study Proposal

HRIPT testing, SPF in-vivo testing, cosmetic efficacy studies, and Phase I-III clinical trials. CDSCO-approved CRO with NABL-accredited bioanalytical labs.

+91-7428116100 Request a Study Proposal