Auriga Research - Clinical Research Division
ICH-GCP Compliant | USFDA Inspected

Clinical Research

Ethical, data-driven clinical studies across pharmaceuticals, cosmetics, nutraceuticals, Ayurveda, and food — delivering reliable evidence that supports regulatory approvals and market claims.

Science. Integrity. Global Compliance.

The Clinical Research Division of Arbro Group

Clinical Research at Auriga Research conducts ethical, data-driven studies across pharmaceuticals, cosmetics, nutraceuticals, Ayurveda, and food — delivering reliable evidence that supports regulatory approvals and market claims.

Our end-to-end clinical research capabilities span trial management, pharmacovigilance, medical writing, data management, biostatistics, regulatory submissions, and claim substantiation. We operate in full compliance with ICH-GCP, BIS, and Schedule Y guidelines.

We also offer non-regulatory claim substantiation studies for cosmetics and food products. Our labs are USFDA-inspected, NABL-accredited, and WHO-prequalified.

Clinical research laboratory - Auriga Research
Clinical trial data management Pharmacovigilance team at work
500+Clinical Studies
ICH-GCPCompliant
Phase I-IVClinical Trials
USFDAInspected
Our Focus

Focus Areas

01

Ethical Excellence

Every clinical study is conducted with the highest ethical standards, adhering to ICH-GCP guidelines, BIS standards, and Schedule Y requirements.

02

Data Integrity

Robust clinical data management and biostatistics ensure integrity, traceability, and regulatory-grade quality across all study endpoints.

03

Timely Delivery

Efficient trial management and streamlined workflows ensure on-time delivery of study milestones without compromising scientific rigor.

What We Offer

Core Offering

01

Pharmacovigilance & Drug Safety

Comprehensive pharmacovigilance systems including adverse event reporting, signal detection, risk management, and post-marketing safety surveillance.

02

Clinical Data Management & Biostatistics

Robust data management systems and expert biostatistical analysis ensuring data integrity, quality, and regulatory compliance across all study phases.

03

Regulatory Submissions

Expert preparation and filing of regulatory dossiers, CTDs, and submissions for CDSCO, USFDA, and global regulatory authorities.

04

Quality Assurance & Compliance Audits

Systematic quality assurance programs and compliance audits ensuring all clinical operations meet ICH-GCP, regulatory, and sponsor requirements.

05

Multicentric Clinical Trial Execution

End-to-end management of multicentric clinical trials across multiple sites, ensuring protocol compliance, patient safety, and data consistency.

06

Medical Writing & Documentation

Expert medical writing services including clinical study reports, investigator brochures, protocols, informed consent forms, and regulatory documents.

End-to-End

Clinical Trial Phases We Support

I

Phase I

First-in-human studies evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers.

II

Phase II

Exploratory efficacy trials to assess therapeutic effectiveness, optimal dosage, and side effects in target patient populations.

III

Phase III

Confirmatory multicentric trials providing definitive evidence of efficacy and safety for regulatory submissions.

IV

Phase IV

Post-marketing surveillance studies monitoring long-term safety, effectiveness, and real-world drug performance.

Industries We Serve

Clinical Research Across Domains

Our clinical research expertise extends beyond pharmaceuticals to cover multiple domains requiring evidence-based validation.

  • Pharmaceuticals — Regulatory clinical trials (Phase I–IV), BA/BE studies
  • Cosmetics & Personal Care — Claim substantiation, dermatological studies
  • Nutraceuticals — Efficacy and safety studies for health supplements
  • Ayurveda & Herbal — Clinical validation of traditional formulations
  • Food & Functional Foods — Health claim substantiation studies
Clinical research across multiple industries
Quality Assurance

Accreditations & Certifications

Our clinical research division operates under strict regulatory oversight with full compliance to ICH-GCP guidelines, BIS standards, and Schedule Y requirements — ensuring every study meets international quality benchmarks.

NABL
CDSCO
ISO
GLP
Get Started

Request a Clinical Research Consultation

Share your clinical research requirements and our team will get back to you within 24 hours with a detailed proposal.

ICH-GCP Compliant International ethical and quality standards
Phase I to Phase IV Complete clinical trial lifecycle support
Multi-Domain Expertise Pharma, cosmetics, nutraceuticals, Ayurveda & food

Partner With Us for Clinical Excellence

USFDA-inspected, NABL-accredited, and WHO-prequalified — our clinical research team delivers the evidence you need.

Request a Consultation