NABL TC-15532 · USFDA Inspected · DCGI Approved · Clinical Research Division

Testing Laboratory in Gurugram (Manesar) | NABL Accredited | USFDA Inspected

USFDA Inspected and DCGI approved analytical lab with an integrated Clinical Research Division.

The Gurugram (Manesar) facility is a 25,000 sq ft USFDA Inspected and DCGI approved (since 1995) analytical laboratory accredited by NABL under ISO/IEC 17025:2017 (Certificate TC-15532). The site uniquely integrates an analytical lab and a Clinical Research Division supporting BA / BE studies, bioanalytical testing, PK / PD studies, HRIPT, and SPF in-vivo claim substantiation per ISO 24444.

Get a Quote Clinical Trial Enquiries Call +91 74281 16100

Lab Overview

Plot 136, Sector 5, IMT Manesar, Gurugram, Haryana 122052

Area: 25,000 sq ft

NABL Certificate: NABL TC-15532

Validity: Valid until February 2029

Hours: Monday to Saturday, 9:00 AM to 6:00 PM

Phone: +91 74281 16100

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NABL TC-15532

Accredited under ISO/IEC 17025:2017

USFDA Inspected

Pharmaceutical testing facility

DCGI Approved

Approved since 1995

25,000 sq ft

Analytical lab + Clinical Research Division

Gurugram Lab (Manesar) — Auriga Research NABL accredited and USFDA inspected testing laboratory at IMT Manesar, Haryana

What the Manesar Lab Tests

NABL TC-15532 covers 21 accredited test entries across pharmaceutical, cosmetics and essential oils, and radiological-water scope. The Clinical Research Division operates separately from the NABL testing scope.

Pharmaceutical

13 parameters

NABL-accredited pharmaceutical testing covering assay, dissolution, stability, and microbiological testing under USFDA Inspected protocols.

Cosmetics & Essential Oils

6 parameters

Physicochemical testing for cosmetics and essential oils, supporting product release and regulatory documentation.

Radiological (Water)

2 parameters

Alpha and Beta emitter analysis in water samples for regulatory and operational reporting.

Integrated Clinical Research Division

Clinical Research at Manesar

Co-located with the analytical lab, the Clinical Research Division conducts BA / BE, bioanalytical, PK / PD, HRIPT, and SPF in-vivo claim substantiation studies for pharmaceutical, nutraceutical, cosmetic, and AYUSH products.

BA / BE Studies

Bioavailability and bioequivalence studies for generic and reformulated pharmaceutical products under DCGI-approved protocols.

Bioanalytical Testing

Bioanalytical method development and validation for clinical sample analysis, supporting PK and PD data generation.

PK / PD Studies

Pharmacokinetic and pharmacodynamic study conduct for pharmaceutical development and lifecycle management.

HRIPT

Human Repeat Insult Patch Test for cosmetic and personal care claim substantiation and sensitisation assessment.

SPF In-Vivo Claim Substantiation

SPF in-vivo testing per ISO 24444 for sunscreen and cosmetic claim substantiation.

Safety & Efficacy Studies

Safety and efficacy studies for pharmaceutical, nutraceutical, cosmetic, and AYUSH products under regulatory protocols.

Clinical Trial Enquiries →

Accreditations & Approvals

NABL accreditation
NABLISO/IEC 17025:2017
CDSCO accreditation
CDSCODrug regulator
FSSAI accreditation
FSSAIFood regulator
WHO Prequalified accreditation
WHO PrequalifiedBangalore lab
BIS accreditation
BISIS standards
USFDA accreditation
USFDAInspected
AYUSH accreditation
AYUSHMinistry registered
APEDA accreditation
APEDAExport approval
ISO accreditation
ISO9001 / 22000
EIC accreditation
EICExport Inspection
NABL accreditation
NABLISO/IEC 17025:2017
CDSCO accreditation
CDSCODrug regulator
FSSAI accreditation
FSSAIFood regulator
WHO Prequalified accreditation
WHO PrequalifiedBangalore lab
BIS accreditation
BISIS standards
USFDA accreditation
USFDAInspected
AYUSH accreditation
AYUSHMinistry registered
APEDA accreditation
APEDAExport approval
ISO accreditation
ISO9001 / 22000
EIC accreditation
EICExport Inspection

Key Instruments at Manesar

Analytical instrumentation across pharmaceutical assay, dissolution, bioanalytical, particle size, and thermal analysis workflows.

HPLC with UV Detector × 5

High-performance liquid chromatography with UV detection across pharmaceutical assay and impurity profiling.

UPLC

Ultra-performance liquid chromatography for high-resolution analytical separations and rapid method workflows.

LC-MS/MS

Liquid chromatography tandem mass spectrometry for bioanalytical sample quantitation, impurity profiling, and trace analysis.

GC × 2

Gas chromatography for residual solvents, volatile organics, and pharmaceutical assay workflows.

DSC

Differential scanning calorimetry for thermal analysis, polymorph identification, and stability characterisation.

Malvern Mastersizer 3000

Laser diffraction particle size analysis for solid dosage forms, suspensions, and inhalation products.

AAS

Atomic absorption spectroscopy for elemental analysis in pharmaceutical and cosmetic matrices.

Autotitrator

Automated potentiometric titration for pharmacopoeial assay determinations and routine analytical workflows.

Dissolution Apparatus × 2

USP apparatus dissolution testing for solid and semi-solid dosage forms.

Disintegration Apparatus

Pharmacopoeial disintegration testing for tablets, capsules, and oral solid dosage forms.

Karl Fischer Titrator

Moisture and water content determination for solid, semi-solid, and liquid samples.

Microwave Digestor

Closed-vessel microwave digestion for heavy metals sample preparation across pharmaceutical and cosmetic matrices.

Refrigerated Centrifuge

Temperature-controlled centrifugation for bioanalytical sample processing and clinical study workflows.

UV-Vis Spectrophotometer

Quantitative assay, content uniformity, and routine determinations across pharmaceutical and cosmetic matrices.

Deep Freezer × 3

Ultra-low temperature deep freezers for bioanalytical sample storage at clinical study temperatures.

Industries Served from Manesar

Six buyer profiles use the Manesar facility for USFDA Inspected analytical work and integrated clinical research.

Pharmaceutical Companies (Gurugram-NCR)

Pharmaceutical companies in the Gurugram-NCR corridor requiring USFDA Inspected lab reports for ANDA, NDA, and CDSCO submissions.

Clinical Study Sponsors

Clinical study sponsors requiring BA / BE, pharmacokinetic, and safety study conduct under DCGI-approved protocols.

Cosmetics Brands

Cosmetics brands requiring USFDA-backed stability and safety reports for international submissions and buyer due diligence.

SPF Claim Substantiation Clients

Sunscreen and cosmetic brands requiring SPF in-vivo claim substantiation per ISO 24444 with human volunteer studies.

Nutraceutical Brands

Nutraceutical and supplement brands requiring safety and efficacy studies via the Clinical Research Division.

AYUSH & Herbal Manufacturers

AYUSH and herbal product manufacturers requiring safety, efficacy, and claim substantiation studies via the Clinical Research Division.

How to Send Samples

Four steps for lab samples. For clinical study enquiries, contact the Clinical Research Division separately.

01

Contact the SPOC

Call your single point of contact at +91 74281 16100 to confirm the test scope, applicable standard, and sample quantity for your matrix.

02

Drop Off or Courier

Drop the sample at the IMT Manesar address or send by pre-approved courier. Each sample is bar coded on receipt and registered in YLIMS.

03

Clinical Study Enquiry

For clinical study enquiries (BA / BE, PK / PD, HRIPT, SPF in-vivo), contact the Clinical Research Division separately for protocol development and quotation.

04

Track via YLIMS

Track your lab samples, status, and digital report via YLIMS. Standard TAT is 5 to 7 working days for analytical testing. Clinical study timelines follow study protocol.

Read the full sample submission guide

Find the Manesar Lab

Plot 136, Sector 5, IMT Manesar, Gurugram, Haryana 122052.

Coordinates: 28.3693, 76.9233

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Frequently Asked Questions, Manesar Lab

What is unique about the Gurugram (Manesar) lab?
The Manesar facility is Auriga's USFDA Inspected and DCGI approved (since 1995) analytical laboratory with an integrated Clinical Research Division. NABL TC-15532 covers 21 test entries across Pharmaceutical (13 parameters), Cosmetics and Essential Oils (6 parameters), and Radiological-Water (2 parameters). The integrated Clinical Research Division conducts BA / BE studies, bioanalytical testing, PK / PD studies, HRIPT, SPF in-vivo claim substantiation (ISO 24444), and safety / efficacy studies.
Is the Manesar lab USFDA Inspected and DCGI approved?
Yes. The Manesar facility is US FDA Inspected and has been DCGI approved since 1995. Additional credentials include NABL accreditation under ISO/IEC 17025:2017 (TC-15532), ISO 9001:2015, Form-37 drug testing licence, COS 23 cosmetics conformity, and AERB recognition. Reports are accepted for ANDA, NDA, CDSCO submissions, and international filings.
How do I submit analytical samples versus clinical study enquiries?
For analytical lab testing, call the SPOC at +91 74281 16100 to confirm scope and submit samples at the IMT Manesar address (Plot 136, Sector 5, IMT Manesar, Gurugram, Haryana 122052) or by pre-approved courier. For clinical study enquiries (BA / BE, PK / PD, HRIPT, SPF in-vivo), contact the Clinical Research Division separately for protocol development, feasibility, and quotation.
Can the Manesar lab perform SPF in-vivo claim substantiation?
Yes. The Manesar Clinical Research Division performs SPF in-vivo testing per ISO 24444 with human volunteer panels for sunscreen and cosmetic SPF claim substantiation. The CRD also conducts HRIPT, cosmetic efficacy, and safety / sensitisation studies for pharma, nutraceutical, cosmetic, and AYUSH product claims.

Get a Quote from This Lab

NABL TC-15532 accredited pharmaceutical testing with USFDA Inspected protocols and integrated Clinical Research Division. Standard analytical TAT 5 to 7 working days.

+91-7428116100 Get a Quote from This Lab

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