NABL ISO/IEC 17025:2017USFDA Inspected (Manesar & Bangalore)CDSCO ApprovedGLP Compliant

Pharmaceutical Testing & QC

Pharmaceutical Testing Laboratory India | NABL, USFDA Inspected & CDSCO Approved

Auriga Research is a NABL-accredited (ISO/IEC 17025:2017) pharmaceutical testing laboratory operating under GLP-compliant conditions, with USFDA-Inspected facility credentials at Manesar and Bangalore, plus CDSCO Form-37 drug-testing licences. We support drug manufacturers, CROs, and regulatory consultants with stability studies, dissolution testing, HPLC analysis, microbiological testing, thermal analysis, and in-vitro permeation studies. 5 labs across Delhi HQ, Manesar (USFDA Inspected), Bahadurgarh, Baddi (HP — pharma manufacturing hub), and Bangalore (USFDA Inspected · WHO Prequalified).

Get a Quote Call +91-7428116100

Accreditations & Approvals

NABLISO/IEC 17025:2017

CDSCODrug regulator

FSSAIFood regulator

WHO PrequalifiedBangalore lab

BISIS standards

USFDAInspected

AYUSHMinistry registered

APEDAExport approval

ISO9001 / 22000

EICExport Inspection

NABLISO/IEC 17025:2017

CDSCODrug regulator

FSSAIFood regulator

WHO PrequalifiedBangalore lab

BISIS standards

USFDAInspected

AYUSHMinistry registered

APEDAExport approval

ISO9001 / 22000

EICExport Inspection

Turnaround Times

Typical report delivery by test type. Express service available for time-critical regulatory submissions.

Test Type	Standard TAT	Express
HPLC Assay / Related Substances	5–7 working days	Available
Stability Studies (ICH protocol)	Per ICH Q1A timelines (6–36 months)	Protocol-bound
Sterility Testing	17–21 working days	Protocol-bound
Method Development & Validation	3–4 weeks	Protocol-bound
TGA / DSC Thermal Analysis	5–7 working days	Available
Franz Diffusion Studies	10–15 working days	Available
Microbiological (Microbial Limits)	10–14 working days	Protocol-bound
Dissolution Testing	7–10 working days	Available

The Challenge

Pharmaceutical companies face stringent regulatory timelines for ANDA, NDA, and CDSCO submissions. Analytical data must come from accredited laboratories following validated methods. Delays in testing mean delayed product launches and lost market opportunity.

Our Solution

Auriga Research provides NABL-accredited (ISO/IEC 17025:2017) pharmaceutical testing with submission-ready data packages. Our validated methods, GLP-compliant laboratory, and regulatory-experienced analysts ensure data integrity and acceptance by CDSCO, USFDA, and international agencies.

Pharmaceutical Testing Services

End-to-end pharmaceutical analytical services from method development to stability studies — categorized by discipline.

Analytical Services

Analytical Development

Method development, feasibility screening, and analytical technique selection for novel drug substances.

Deformulation & Reverse Engineering

Product composition analysis and reverse engineering for pharmaceutical and consumer products.

Method Development & Validation

ICH Q2(R2) and Q14 method validation for ANDA/NDA submissions with complete validation reports.

HPLC Testing

Assay, related substances, content uniformity, and impurity profiling by HPLC/UHPLC.

VOC Testing

Volatile organic compound testing and analysis for pharmaceutical, cosmetic, and consumer products.

Elemental Analysis

ICP-MS elemental impurity testing per ICH Q3D(R2) for drug products and APIs.

Quality Testing

Raw Material Testing

Identity, purity, and quality testing of APIs and excipients per pharmacopoeial specifications.

Liquid Glucose Testing for Industry

NABL accredited liquid glucose testing for pharmaceutical and industrial food applications.

Asbestos Detection in Pharmaceutical Talc

NABL accredited asbestos detection and mineralogical testing for pharmaceutical-grade talc and talc-based materials.

Excipient Testing

Quality testing for pharmaceutical excipients including identity, moisture, microbial limits, and functional properties.

Finished Product Testing

QC release testing for tablets, capsules, injectables, and semisolid formulations.

Photostability Testing

ICH Q1B photostability studies for pharmaceutical products.

Stability Testing

ICH Q1A-Q1E compliant accelerated, intermediate, and long-term stability studies.

Dissolution Testing

USP apparatus I-IV dissolution profiling, f2 similarity factor, and QC release testing.

Microbiology & Safety

Microbiological Testing

Microbial limits, sterility testing, and preservative efficacy per USP and IP methods.

Bacterial Endotoxin Testing

LAL-based endotoxin testing for injectables, medical devices, and water systems.

Hand Sanitizer Testing

Alcohol assay, methanol contamination (200 ppm), EN 1500 / ASTM E1174 efficacy, and BIS IS 17390 conformity for alcohol-based hand rubs.

Impurity & Characterization

Impurity Profiling

Organic and inorganic impurity identification and quantification per ICH Q3A/Q3B.

Nitrosamine Testing

NDMA, NDEA, and N-nitrosamine impurity analysis per FDA/EMA guidance.

XRD Testing

Powder X-ray diffraction for polymorphic form identification and crystallinity assessment.

Solid State Characterization

Comprehensive solid-state analysis combining XRD, DSC, TGA, and spectroscopic methods.

Thermal & Physical

TGA Analysis

Thermogravimetric analysis for moisture, residual solvents, and thermal stability.

DSC Analysis

Differential scanning calorimetry for melting point, glass transition, and polymorphism.

Franz Diffusion Testing

In-vitro drug release and permeation for topical and transdermal formulations.

Particle Size Analysis

Laser diffraction and dynamic light scattering for API and formulation particle sizing.

Why Choose Auriga for Pharma Testing

Pharma-specific credentials and capacity that make Auriga the testing partner of choice for CDSCO, USFDA, and WHO-route dossier work.

NABL Accredited Across 5 Labs

NABL accredited (ISO/IEC 17025:2017) across all 5 labs with 600+ validated analytical methods covering the full pharmacopoeial scope (USP, IP, EP, BP, JP).

USFDA Inspected at Manesar & Bangalore

The only Indian testing labs with USFDA Inspected status at two sites — Manesar and Bangalore. Data accepted in USFDA dossiers without re-testing.

CDSCO Form-37 Drug-Testing Licence

CDSCO Form-37 approved drug-testing licence at Delhi, Manesar, and Baddi. Reports accepted for State Drug Controller and CDSCO submissions.

110+ HPLC Systems · 605 Columns

110+ HPLC and UPLC systems across the 5-lab network with 605 chromatography columns in active stock. No backlog for routine pharma QC release testing.

WHO Prequalified at Bangalore

WHO Prequalified status at the Bangalore lab for international procurement and WHO-route dossier submissions.

ICH Q2(R2) + Q14 Method Framework

Method development and validation delivered against the current ICH Q2(R2) (March 2024) and Q14 (2023) framework. Documentation built for direct Module 3 inclusion.

NABL Accredited Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group · Auriga Research

Auriga Research is the testing division of the Arbro Group — serving pharmaceutical, food, environmental, and consumer-product clients since 1985.

Accreditation and Regulatory Compliance

Auriga Research holds NABL accreditation under ISO/IEC 17025:2017 for pharmaceutical testing. Our laboratory operates under GLP-compliant conditions with full compliance to USFDA 21 CFR Part 211, CDSCO Schedule M, ICH guidelines, and Indian Pharmacopoeia requirements. Our facility has been USFDA inspected.

Analytical methods are validated per ICH Q2(R2) (March 2024) and ICH Q14 (2023) with complete validation reports including specificity, linearity, accuracy, precision, LOD/LOQ, and robustness. All data is generated with electronic audit trails, ensuring data integrity per ALCOA+ principles required by USFDA, WHO Prequalification, and CDSCO.

Our Pharmaceutical Testing Labs — 5 Cities

Delhi Laboratory

Arbro Analytical Division · HQ

Full analytical suite including HPLC, ICP-MS, TGA, DSC, and stability chambers. Central location for Delhi NCR pharma clients.

Manesar Laboratory

USFDA Inspected · Method Dev & Validation

Plot 136, Sector 5, IMT Manesar. The USFDA Inspected facility anchoring method development, ICH Q2(R2) validation, and UPLC work.

Bahadurgarh Laboratory

NABL TC-7710 · Specialty Pharma Work

Specialty NABL-accredited testing under TC-7710 covering pharma-adjacent and environmental analytical scope. Part of the 5-city Auriga lab network.

Baddi Laboratory

Himachal Pradesh · Pharma Manufacturing Hub

Strategically located in Baddi, India's largest pharmaceutical manufacturing cluster. HPLC, UPLC, and ICP-MS for local manufacturers.

Bangalore Laboratory

USFDA Inspected · WHO Prequalified

USFDA Inspected and WHO Prequalified site serving South India's pharma, biotech, and CRO ecosystem. Multiple HPLC and ICP-MS units.

Proven Track Record

A mid-size pharmaceutical company needed accelerated stability data for an ANDA submission within a tight FDA deadline. Auriga Research initiated the 6-month accelerated study with validated HPLC methods, delivering interim 3-month data within 4 months of study start. The complete submission package — including method validation, stability data, and certificates of analysis — was accepted by USFDA without analytical deficiencies.

Start Your Pharmaceutical Testing

NABL-accredited (ISO/IEC 17025:2017), USFDA-inspected, CDSCO-approved, GLP-compliant pharmaceutical testing with submission-ready data packages. Contact us for a detailed proposal.

+91-7428116100 Get a Quote

Frequently Asked Questions

What pharmaceutical tests does Auriga Research perform?

We offer a comprehensive range of pharmaceutical testing services including stability studies (ICH Q1A-Q1E conditions), dissolution testing (USP apparatus I-IV), microbiological testing (microbial limits, sterility, endotoxin), HPLC analysis (assay, related substances, content uniformity), thermal analysis (TGA, DSC), Franz diffusion for topical formulations, and physicochemical characterisation. Testing follows USP, IP, BP, EP, and ICH guidelines.

Is Auriga Research USFDA inspected?

Yes. Auriga Research maintains NABL accreditation under ISO/IEC 17025:2017 and operates under GLP-compliant laboratory conditions aligned with USFDA 21 CFR Part 211 requirements. Our facility has been USFDA inspected. Analytical methods follow USP, ICH, and FDA guidance documents. Test reports are accepted by CDSCO, USFDA, and international regulatory agencies for drug product submissions.

How long do stability studies take?

Stability study duration depends on the protocol. Accelerated stability studies (40 deg C / 75% RH) run for 6 months per ICH Q1A(R2). Long-term stability studies (25 deg C / 60% RH or 30 deg C / 65% RH) typically run for 12-36 months. Intermediate conditions (30 deg C / 65% RH) run for 6-12 months. Initial analytical results from the first time point are typically available within 2-3 weeks of study initiation.

What is the turnaround time for pharmaceutical testing?

Turnaround varies by test type. HPLC assay and related substances: 5-7 working days. Dissolution profiling: 7-10 working days. Microbiological testing (microbial limits): 10-14 working days. Sterility testing: 17-21 working days (14-day incubation per USP <71> plus reporting). TGA/DSC thermal analysis: 5-7 working days. Franz diffusion studies: 10-15 working days depending on the protocol. Method development and validation: 3-4 weeks. Express service is available for time-critical submissions.

Do you support ANDA and NDA filings?

Yes. Our pharmaceutical testing data packages are formatted for ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) submissions to USFDA and CDSCO. We provide validated analytical methods, method validation reports per ICH Q2(R2) (March 2024) and ICH Q14 (2023), stability data per ICH Q1A(R2), and certificates of analysis — all in submission-ready format with complete audit trails.