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Infrastructure

Our Expertise

Regulatory History

Regulatory History

Regulatory History

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

Late Phase

Late Phase (II–IV)

Late Phase (II–IV)

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

Biologics

Biologics

Biologics

Characterization, Clinical comparability (PK/PD), and Immunogenicity studies for Biosimilars.

CDM & Biostatistics

CDM & Biostatistics

CDM & Biostatistics

Comprehensive data management, registry analysis, HEOR, and real-world evidence analytics.

Regulatory History

Globally trusted, compliant clinical research.

Accutest Biologics is a DCGI approved facility, with current approval valid from September 2021 to September 2026. We maintain the highest standards of compliance, ensuring full GCLP/GLP adherence. Our team is committed to delivering reliable, scientifically robust, and ethically sound biologics services.

Quality Assurance at Accutest

Trusted QA ensuring safe, compliant clinical research.

Standard Operating Procedures (SOPs)

Structured SOPs ensure consistent, compliant, high quality operations.

Mumbai Clinic Infrastructure

State of the art Mumbai clinic supporting large BA/BE and clinical trials.

Our Mumbai site operates under the highest standards of quality and compliance. The facility proudly holds multiple prestigious regulatory approvals, including DCGI, MHRA, MCC, USFDA, WHO, EMA, ANVISA, and NPRA Malaysia, underscoring our commitment to globally benchmarked clinical practices. With robust infrastructure, advanced clinical systems, and strict adherence to GCP guidelines, the Mumbai clinic reflects Accutest’s dedication to scientific rigor, participant care, and reliable study outcomes.

Vadodara Clinic Infrastructure

Accutest’s Vadodara clinic is our largest and most advanced clinical research facility, featuring 140 beds spread across a spacious 29,000 sq. ft. area. Its strategic location in Vadodara home to several leading pharmaceutical companies ensures excellent accessibility to a diverse and reliable patient pool, enabling faster and more efficient volunteer recruitment. The clinic is built to support high volume BA/BE studies

Bio-analytical Lab

Advanced Bio Analytical Laboratories

Accutest’s bio analytical capability is strengthened by an extensive range of 21 LC MS/MS systems, enabling high throughput analysis with superior sensitivity and accuracy. Our infrastructure includes 2 API 6500+, 12 API 5500, 2 API 4500, and 2 API 4000 instruments, ensuring robust analytical performance across diverse study requirements.

Processing labs

Balance rooms

Deepfreezer rooms

ICP OES for elemental analysis

BA/BE Regulatory Approvals

World map

Biologics Services in numbers

CELL LINES

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ELISA Studies

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CELL BASED ASSAYS

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TEAM

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PROTETIN CHARATERIZATION STUDIES

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MOLECULAR BIOLOGY

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IT Infrastructure

Our Advanced IT Infrastructure and Compliance-Driven Digital Ecosystem

At Accutest Global we provide a world class IT environment designed for pharmaceutical, biotech, and life sciences organizations that demand reliability, compliance, and data integrity. Our infrastructure integrates advanced technologies with global regulatory standards, ensuring a secure, validated, and audit ready digital ecosystem.

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