Infrastructure

service

Regulatory History

140+ regulatory audits

service

Late Phase(Phase II-IV)

Phase II to IV studies for small/large molecules, PMS, Nutraceuticals,  therapeutic equivalence, clinical end point

Biologics

Characterization, Clinical comparability (PK / PD, studies), Immunogenicity studies for Biosimilar products

CDM & Biostatistics and real world Evidence

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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.

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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
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BA/BE - Regulatory Approvals

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Biologics Lab

Advanced biologics expertise for comprehensive research.

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Comprehensive cell biology services for characterization, assays, and research.

Comprehensive ELISA platform for PK, immunogenicity, biomarkers, impurities.

Flow cytometry supporting immunology, PBMC studies, and preclinical research.

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.

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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