CDSCO Approved · ICH-GCP Compliant

Clinical Research Organization in India | CDSCO Approved CRO Services

Auriga Research is a CDSCO-approved clinical research organization (CRO) in India with over three decades of experience in pharmaceutical and clinical sciences. We provide end-to-end contract research organization services spanning Phase I through Phase III clinical trials, bioanalytical testing, pharmacovigilance, biostatistics, clinical data management, site management, and regulatory submissions.

Our CRO division operates under ICH-GCP (E6 R2) guidelines, the New Drugs and Clinical Trials Rules 2019, and Schedule Y requirements. With NABL-accredited bioanalytical laboratories equipped with LC-MS/MS, HPLC, and immunoassay platforms, we deliver pharmacokinetic and drug safety data that regulatory authorities accept without question.

As one of the established CRO companies in India, Auriga Research combines clinical trial execution with integrated analytical and manufacturing capabilities — a rare combination that accelerates timelines and reduces sponsor coordination overhead. Our clinical research teams work across therapeutic areas including oncology, cardiology, dermatology, nutraceuticals, and cosmetics.

Request a CRO Proposal Call +91-7428116100

Why CDSCO Approval Matters

CDSCO (Central Drugs Standard Control Organisation) approval is mandatory for conducting clinical trials in India. It validates that a CRO meets safety, ethical, and scientific standards set by India's apex drug regulatory authority.

700+

Scientists and technical staff across clinical, analytical, and manufacturing divisions

Since 1985

Continuously operating pharmaceutical research and testing laboratory in Delhi

NABL + USFDA

Dual accreditation under ISO/IEC 17025:2017 with USFDA registration and WHO pre-qualification

CRO Services

Full-spectrum contract research organization services — from protocol design and clinical trial execution to final regulatory submission.

Clinical Trials & Bioanalytical Testing

Phase I-III clinical trials, HRIPT testing, SPF in-vivo testing, cosmetic efficacy clinical studies, and bioanalytical method development with LC-MS/MS.

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Pharmacovigilance

Post-marketing surveillance, adverse event reporting, periodic safety update reports (PSURs), and signal detection aligned with CDSCO and ICH E2 guidelines.

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Biostatistics & Data Management

Statistical analysis plans, randomisation, CDISC-compliant data management, interim analyses, and sample size calculations for regulatory submissions.

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Site Management

Clinical trial site identification, investigator selection, site initiation, patient recruitment support, and monitoring across multi-centre studies in India.

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Medical Writing & Regulatory Submissions

CTD-format dossier preparation, clinical study reports, IBs, protocols, ICFs, and regulatory submission packages for CDSCO, FDA, and EMA.

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Therapeutic Areas & Study Types

Pharmaceutical & Biotech

  • ✓ Bioequivalence and bioavailability studies
  • ✓ Phase I first-in-human dose escalation
  • ✓ Phase II/III multi-centre efficacy trials
  • ✓ Pharmacokinetic and pharmacodynamic studies
  • ✓ Post-marketing surveillance (Phase IV)

Cosmetics & Personal Care

  • ✓ HRIPT (Human Repeat Insult Patch Test)
  • ✓ SPF in-vivo testing (ISO 24444)
  • ✓ Cosmetic efficacy clinical studies
  • ✓ Dermal safety and tolerance studies
  • ✓ Anti-ageing and moisturisation claims support

How We Work

A structured approach from feasibility assessment to final regulatory submission — designed to keep your study on timeline and budget.

01

Feasibility & Proposal

We assess your study requirements, therapeutic area, regulatory pathway, and timeline. You receive a detailed proposal with cost breakdown and milestones within 5 business days.

02

Regulatory & Ethics

Our regulatory team prepares CDSCO submissions, Ethics Committee applications, CTRI registration, and all required approvals before first patient enrolment.

03

Trial Execution

Site initiation, patient recruitment, data capture, monitoring, and bioanalytical sample analysis — all managed by dedicated project teams with real-time progress reporting.

04

Reporting & Submission

Clinical study reports per ICH E3, statistical analyses, regulatory dossier compilation, and submission support for CDSCO, FDA, or EMA pathways.

Related Services

Auriga Research's CRO capabilities are complemented by our testing laboratories and CDMO division — providing an integrated development pathway from formulation to market.

Pharmaceutical Testing Analytical, stability, microbiology Cosmetics Testing Lab Safety, efficacy, regulatory compliance CDMO Services Contract manufacturing & formulation Nutraceutical Testing FSSAI, AYUSH, stability testing Medical Device Testing Biocompatibility, safety, performance Clinical Trial Services Existing clinical trial capabilities

Frequently Asked Questions

What is a Clinical Research Organization (CRO)?
A Clinical Research Organization (CRO) is a company that provides outsourced research services to pharmaceutical, biotechnology, and medical device companies. CROs manage clinical trials, bioanalytical testing, pharmacovigilance, regulatory submissions, and data management on behalf of sponsors. Auriga Research operates as a CDSCO-approved CRO in India, handling Phase I through Phase III clinical trials with full regulatory compliance.
Is Auriga Research approved by CDSCO for clinical trials?
Yes. Auriga Research holds CDSCO approval for conducting clinical trials in India. Our clinical research operations comply with the New Drugs and Clinical Trials Rules, 2019, Schedule Y requirements, and ICH-GCP (E6 R2) guidelines. We maintain Ethics Committee approvals, investigator qualifications, and site infrastructure that meet CDSCO inspection standards.
What types of clinical studies does Auriga Research conduct?
Auriga Research conducts Phase I (first-in-human), Phase II (dose-finding), and Phase III (pivotal efficacy) clinical trials. We also perform bioanalytical testing, pharmacokinetic studies, cosmetic efficacy clinical studies including HRIPT and SPF in-vivo testing, pharmacovigilance, and post-marketing surveillance studies. Our capabilities span pharmaceuticals, cosmetics, nutraceuticals, and medical devices.
What are the advantages of conducting clinical trials in India?
India offers several advantages for clinical research: a large, treatment-naive patient population with diverse disease profiles; cost efficiency (typically 40-60% lower than Western markets); a robust regulatory framework under CDSCO aligned with ICH guidelines; experienced clinical investigators and research sites; and English-speaking medical professionals. Auriga Research leverages these advantages while maintaining international quality standards.
How does Auriga Research ensure data integrity in clinical trials?
Data integrity is maintained through CDISC-compliant electronic data capture (EDC) systems, 21 CFR Part 11 compliant audit trails, independent data monitoring committees, source data verification by trained monitors, and statistical quality control checks. Our biostatistics team follows pre-specified statistical analysis plans, and all clinical study reports are prepared per ICH E3 guidelines.

Start Your Clinical Research Project

CDSCO-approved CRO with Phase I-III trial capabilities, NABL-accredited bioanalytical labs, and integrated CDMO services. Get a detailed proposal within 5 business days.

+91-7428116100 Request a CRO Proposal

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