NABL · USFDA · WHO PQ · GLP · 21 CFR Part 11

Regulatory Filing Testing India: CDSCO, FDA, and EMA Dossier Support

Validated with Confidence.

A regulatory dossier is only as strong as the analytical data supporting it. CDSCO, FDA, and EMA reviewers check method validation packages, data audit trails, and accreditation scope certificates as part of standard dossier review. Auriga Research provides NABL-accredited, US FDA-registered analytical testing with 21 CFR Part 11 compliant data management, so your test data arrives at the regulatory authority in exactly the form they expect to see.

Backed by the Arbro Group's analytical heritage, with Arbro Lab operational since 1990 and Auriga Research founded in 2007, the group has held NABL accreditation continuously since 2003 without a single break. The laboratory is US FDA-registered, WHO Prequalified, and GLP-certified for the applicable scope.

Discuss Your Dossier Testing Requirements Call +91-7428116100

Regulatory Credentials

Four credentials that regulatory reviewers expect to see referenced in the dossier package supporting analytical data.

ISO/IEC 17025:2017 accreditation for the analytical and testing scope.

US FDA-registered facility for analytical work supporting US dossier filings.

WHO Prequalification recognition supporting WHO PQ analytical workflows.

GLP-certified operations for nonclinical and analytical work where GLP is required.

Who Needs This

Six regulatory affairs profiles use Auriga's dossier testing service across pharmaceutical, medical device, nutraceutical, AYUSH, and cosmetics submissions.

Pharma Companies Filing CDSCO Dossiers

Pharmaceutical companies preparing CDSCO new drug applications, import licences, and post-approval variations under the New Drugs and Clinical Trials Rules 2019.

ANDA and NDA Filers for US FDA

Companies preparing ANDA, NDA, and supporting analytical work for US FDA submissions, including stability, impurity profile, and dissolution data.

WHO PQ and EMA Applicants

Sponsors pursuing WHO Prequalification of finished pharmaceutical products and EMA Marketing Authorisation, with Module 3 quality data per ICH M4.

Medical Device Manufacturers

Medical device manufacturers building ISO 10993 technical files for compliance with the Medical Devices Rules 2017 and CDSCO submissions.

Nutraceutical & AYUSH Product Filers

Companies filing FSSAI Nutraceutical and AYUSH product approvals requiring analytical, stability, and identity data aligned to receiving-authority requirements.

Cosmetics Manufacturers Filing Internationally

Cosmetics manufacturers preparing CDSCO cosmetic registration and US FDA MoCRA-aligned analytical packages for international market entry.

Why Auriga

Six reasons regulatory affairs teams choose Auriga as their analytical testing partner for dossier submissions.

NABL Accreditation Under ISO/IEC 17025:2017

NABL accreditation under ISO/IEC 17025:2017 held continuously by the Arbro Group since 2003 without a single break, with scope certificate available on request.

US FDA Registered, WHO PQ and GLP

US FDA-registered facility, WHO Prequalification recognition, and GLP-certified operations for nonclinical and analytical work where required by the receiving authority.

21 CFR Part 11 Compliant Data Management

YLIMS, our Laboratory Information Management System, runs 21 CFR Part 11 compliant electronic records with full audit trail, electronic signatures, and access controls.

ICH Q1A Stability Chambers

ICH Q1A(R2) stability chambers with controlled documentation and continuous monitoring, supporting Zone IVa, IVb, II, and other long-term and accelerated programmes.

ICH-Aligned Analytical Methods

Method validation per ICH Q2(R1), impurity profiling per ICH Q3A and Q3B, and stability work aligned to current ICH stability guidelines for the applicable climatic zone.

Track Record in CDSCO, FDA, and EMA Filings

Auriga's analytical data has been accepted in CDSCO, FDA, and EMA filings. References and case studies are available under NDA at proposal stage.

ICH Reference Framework

Analytical work is referenced to the applicable ICH guideline so the data and supporting documentation match what the regulatory reviewer expects to see in the dossier.

ICH Reference	Application
ICH Q1A(R2)	Stability testing of new drug substances and products. Long-term, intermediate, and accelerated programmes by climatic zone.
ICH Q2(R1)	Validation of analytical procedures, including specificity, linearity, accuracy, precision, range, detection and quantification limits, and robustness.
ICH Q3A(R2)	Impurity profile in new drug substances, qualification thresholds, and reporting.
ICH Q3B(R2)	Impurity profile in new drug products, including degradation products.
ICH Q3D	Elemental impurities, control strategy, and risk assessment under PDE limits.
ICH M7(R1)	Assessment and control of DNA reactive (mutagenic) impurities, including nitrosamine workflows.

How It Works

Four steps from initial scope definition to dossier-ready analytical report.

01

Define Your Scope

Share your regulatory target and the dossier modules requiring analytical support. Your SPOC maps the required methods, validation packages, and documentation standards before any testing begins.

02

Send Your Sample

Samples arrive with a completed Test Request Form referencing the regulatory submission scope. Each sample is registered in YLIMS and testing begins within 24 hours under GLP conditions.

03

Testing and Review

Methods are executed against validated protocols and results pass formal internal QA review. Data is generated under 21 CFR Part 11 compliant audit trail.

04

Receive Your Report

Your NABL-accredited, dossier-ready report is delivered digitally with full raw data and audit trail documentation in the format required by your regulatory authority.

Related Services

Pharmaceutical Testing Analytical, dissolution, microbiology, impurity profile, and method development work supporting dossier submissions. Stability Testing ICH Q1A(R2) stability chambers for accelerated, intermediate, and long-term programmes by climatic zone. Medical Writing eCTD module preparation, Sugam portal submission, CSRs, and dossier writing aligned with the analytical package. Method Development & Validation Method development and validation per ICH Q2(R1) for active ingredient quantification and impurity profiles. NABL Accredited Lab ISO/IEC 17025:2017 accreditation, scope certificate available on request. Clinical Trials Phase II–IV regulated clinical trials and bioanalytical support for dossier submissions.

Frequently Asked Questions

Will Auriga's analytical data be accepted in a CDSCO, FDA, or EMA filing?

Auriga's analytical data has been accepted in CDSCO, FDA, and EMA filings. Acceptance depends on the scope of accreditation against the parameter, the method validation package, and the data integrity record. We work with sponsors and consultants at proposal stage to confirm scope, method, and documentation against the receiving authority's expectations.

Do you provide a NABL scope certificate?

Yes. Our NABL scope certificate under ISO/IEC 17025:2017 is provided on request and is referenced in our reports. The accreditation is held continuously by the Arbro Group since 2003 without a single break.

Is your data 21 CFR Part 11 compliant?

Yes. YLIMS, our Laboratory Information Management System, is configured for 21 CFR Part 11 compliance, including electronic records with audit trail, electronic signatures, access controls, and tamper-evident logs. Source records are retained per the relevant ICH retention guidance.

Which ICH guidelines do you follow?

Stability per ICH Q1A(R2), method validation per ICH Q2(R1), impurity profile per ICH Q3A(R2) and Q3B(R2), elemental impurities per ICH Q3D, and DNA reactive impurities per ICH M7(R1). Other ICH and pharmacopoeial guidelines are followed as applicable to the dossier and product type.

Do you support nitrosamine impurity testing?

Yes. Nitrosamine impurity testing follows ICH M7(R1) workflows with LC-MS/MS and other validated approaches as required by the regulatory authority. Risk assessment, method development, validation, and confirmatory testing are all supported.

What is the typical timeline for dossier-grade analytical work?

Stability programmes follow ICH timelines per protocol. Method validation packages typically run 6 to 10 weeks depending on complexity. Routine analytical testing within an accredited scope is typically 5 to 10 working days. Your SPOC confirms exact timelines per dossier scope at proposal stage.

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