NABL Accredited · USFDA Compliant · CDSCO Approved

Pharmaceutical Testing Laboratory India | NABL, USFDA & CDSCO Accredited

Auriga Research is a NABL-accredited pharmaceutical testing laboratory operating under cGMP conditions aligned with USFDA and CDSCO requirements. We support drug manufacturers, CROs, and regulatory consultants with stability studies, dissolution testing, HPLC analysis, microbiological testing, thermal analysis, and in-vitro permeation studies — with labs in Delhi and Baddi (Himachal Pradesh, India's pharma manufacturing hub).

Typical report delivery: 5–15 working days depending on test | Express available

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Accreditations & Approvals

NABL

CDSCO

FSSAI

WHO

BIS

USFDA

AYUSH

APEDA

ISO

EIC

NABL

CDSCO

FSSAI

WHO

BIS

USFDA

AYUSH

APEDA

ISO

EIC

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	14 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 pharmaceutical testing with submission-ready data packages. Our validated methods, cGMP 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.

Method Development & Validation

ICH Q2(R1) method validation for ANDA/NDA submissions with complete validation reports.

HPLC Testing

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

Elemental Analysis

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

Quality Testing

Raw Material Testing

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

Finished Product Testing

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

Stability Testing

ICH Q1A-Q1F 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.

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

NABL-accredited with cGMP laboratory conditions aligned to USFDA 21 CFR Part 211 and CDSCO requirements.

Submission-ready data packages formatted for ANDA, NDA, and CDSCO filings with complete audit trails.

Full analytical suite: HPLC, GC, ICP-MS, DSC, TGA, Karl Fischer, and Franz diffusion cells at our Delhi and Baddi labs.

Accreditation and Regulatory Compliance

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

Analytical methods are validated per ICH Q2(R1) 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, and CDSCO.

Our Pharmaceutical Testing Labs

Delhi Laboratory

Primary Pharmaceutical Testing Hub

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

Baddi Laboratory

Himachal Pradesh — Pharma Manufacturing Hub

Strategically located in Baddi, India's largest pharmaceutical manufacturing cluster. Serving local drug manufacturers with fast turnaround.

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, USFDA & CDSCO-compliant pharmaceutical testing with submission-ready data packages. Contact us for a detailed proposal.

+91-7428116100 Request a Free 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-Q1F 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 compliant?

Yes. Auriga Research maintains NABL accreditation under ISO/IEC 17025:2017 and operates under cGMP-compliant laboratory conditions aligned with USFDA 21 CFR Part 211 requirements. Our 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: 7-10 working days. Dissolution profiling: 7-10 working days. Microbiological testing (microbial limits): 10-14 working days. Sterility testing: 14-21 working days. TGA/DSC thermal analysis: 5-7 working days. Franz diffusion studies: 10-15 working days depending on the protocol. 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(R1), stability data per ICH Q1A, and certificates of analysis — all in submission-ready format with complete audit trails.