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Infrastructure

Our Expertise

Regulatory History

140+ regulatory audits with a proven track record of compliance and excellence.

Late Phase (II–IV)

Phase II to IV studies for small/large molecules and clinical end-point trials.

Biologics

PK/PD, Immunogenicity and Biosimilar characterization studies.

CDM & Biostatistics

Comprehensive data management and real-world evidence analytics.

Strict Quality Practices

New Advanced Instruments

Customized Lab Solutions

Regulatory History

Globally Trusted, Compliant
Clinical Research Facility

At Accutest, regulatory compliance is a core commitment embedded in every aspect of our operations. With 140+ successful global inspections, we uphold the highest standards of quality, safety, and data integrity ensuring dependable, compliant, and transparent clinical and bioanalytical services for our clients worldwide.

DCGI Approved Facility

140+ successful global regulatory inspections Approved by DCGI & NPRA USFDA, WHO, EMA, ANVISA,

GLP / GCLP Adherence

Strong focus on quality, safety & data integrity Proactive regulatory & quality assurance teams

BA/BE Regulatory Approvals by Location

Accutest Research Laboratories is recognized as one of the leading CROs in India with a strong regulatory track record across its clinical research facilities.

MUMBAI FACILITY

Globally Accredited BA/BE CRO

Our Mumbai center operates under the highest standards of quality and compliance. The facility proudly holds prestigious regulatory approvals including DCGI, US FDA, WHO, EMA, ANVISA and NPRA Malaysia.

DCGI US FDA WHO EMA ANVISA NPRA (Malaysia)
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GLOBAL PRESENCE

International Regulatory Approvals

Accutest Research Laboratories holds approvals from leading global regulatory authorities, ensuring international compliance, safety standards and clinical excellence.

DCGI US FDA WHO EMA ANVISA NPRA (Malaysia)
VADODARA FACILITY

Trusted for Complex
Bioequivalence Studies

Our state-of-the-art Vadodara unit is designed to support large-scale, complex clinical trials with strict regulatory compliance. The clinic is built to support high volume BA/BE studies.

DCGI US FDA WHO
Bio Analytical Lab

Advanced Bio-Analytical Infrastructure

Powered by regulatory-approved systems, harmonized SOPs, and precision-driven quality oversight.

Regulatory & Quality Excellence

Precision. Compliance. Integrity.

Globally aligned bio-analytical and biologics operations built on scientific rigor and regulatory strength.

Regulatory Approved

DCGI-approved biologics facility ensuring regulatory credibility and operational excellence.

GLP / GCLP Compliant

Globally aligned laboratory standards maintaining data integrity and audit readiness.

Independent QA Oversight

Dedicated monitoring ensuring data integrity and subject safety.

Secure Document Management

Advanced document control with audit trails and lifecycle traceability.

Continuous Training

Ongoing GLP/GCP training ensuring skilled, regulation-ready teams.

Biologics Lab

Advanced biologics expertise for comprehensive research.

Cell Biology

  • Biological Characterization
  • Cell Based Functional Assay Biosimilarity, NAb Assay
  • Preclinical Research MoA
  • Exploratory Studies
  • Upstream: Transfection & Protein Expression

Flow Cytometry

(Attune, Life Technologies)

  • Immunology & Oncology
  • PBMCs-Based Studies
  • Innate & Adaptive Immunogenicity
  • PD Parameters Hematology
  • Preclinical Research MoA

NGC Chromatography

(NGC Discover Quest 10 Plus, Bio-Rad)

  • Purification Peptides, MAbs, Biomolecules
  • Small R&D Batch Production
  • Scale-Up Purification
  • Protein Refolding
  • Process Development

Nexera X2 UPLC / HPLC

  • Peptide / Amino Acid Analysis
  • Purity & Impurity Profiling
  • Stress Stability Studies
  • IEX & RP-HPLC Analysis
  • SEC-HPLC Aggregation Analysis
  • Drug & Metabolite Quantification
  • Nucleic Acid Analysis
WHAT WE DO

Biologics Services in Numbers

Delivering precision-driven biologics research services with scientific excellence and regulatory expertise.

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CELL LINES

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ELISA Studies

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CELL BASED ASSAYS

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TEAM

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PROTEIN CHARACTERIZATION

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MOLECULAR BIOLOGY

IT Infrastructure

Advanced Digital Ecosystem Built for Compliance & Security

Secure, validated and scalable IT environment designed for pharmaceutical and life sciences organizations.

Our IT backbone is built on Nutanix Hyper Converged Infrastructure (HCI), enabling seamless scalability, reliability, and simplified management of mission critical applications. This architecture supports rapid deployment, high availability, and consistent system performance ideal for regulated environments.
We deploy Fortinet Next Generation Firewalls (NGFW) to ensure enterprise grade protection, secure connectivity, and comprehensive threat visibility. Advanced intrusion prevention, content filtering, and VPN security maintain uninterrupted and compliant network operations across all facilities.
All endpoints are safeguarded by SentinelOne, an AI-driven endpoint detection and response (EDR) solution that autonomously prevents, detects, and mitigates ransomware, malware, and emerging threats ensuring data integrity across every device and user.
Our multi-layered cybersecurity architecture ensures proactive monitoring, advanced threat analytics, and continuous protection. Global regulatory frameworks to maintain data confidentiality, integrity, and availability.
We maintain full Computer System Validation (CSV) in line with GxP, Annex 11, and 21 CFR Part 11 standards. All computerized systems are validated to ensure accuracy, reliability, and traceability of electronic records and signatures.Our validation lifecycle includes risk assessment, IQ/OQ/PQ documentation, audit trails, and change control, ensuring every digital system remains compliant, secure, and inspection-ready for FDA, EMA, and MHRA audits.