GLP-Compliant Preclinical CRO · India

Science that informs every decision

Global regulatory submissions supported

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Pharma · Agro · Devices · Food · Cosmetics

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GLP-compliant preclinical CRO

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OECD & CPCSEA certified

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10+ years of experience

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Company Overview

Vanta Bioscience is a GLP-compliant preclinical contract research organization (CRO) based in India, with over a decade of experience delivering nonclinical safety studies in support of global regulatory submissions. The organization works with sponsors across the pharmaceutical, biopharmaceutical, medical device, agrochemical, and specialty chemical sectors, providing study execution and regulatory documentation aligned with international standards.

 

The company’s core service areas span toxicology, safety pharmacology, and nonclinical study management, with capabilities covering both early-stage screening and definitive regulatory studies. Vanta Bioscience supports clients at various stages of product development—from initial hazard characterization through the preparation of nonclinical dossiers intended for submission to regulatory agencies including but not limited to the CDSCO, US FDA, EMA, and PMDA.

 

Over its operational history, Vanta Bioscience has established working relationships with sponsors ranging from emerging biotech companies to established multinational organizations, providing a consistent, scientifically rigorous service platform adaptable to diverse regulatory requirements and study complexities.

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Scientific & Operational Capability

Vanta manages the complete lifecycle of nonclinical studies internally—from protocol design and ethical review coordination through in-life conduct, bioanalysis, data collection, and final report compilation. This integrated approach ensures continuity of scientific oversight across all phases of a study and reduces the risk of data gaps or miscommunication that can arise from fragmented outsourcing models.


The organization’s scientific teams encompass expertise in study direction, veterinary oversight, pathology, and regulatory affairs, enabling cross-functional collaboration on complex or multi-module programs. This capability is particularly relevant for sponsors requiring studies that must satisfy multiple national and international guidelines simultaneously, or programs that involve combination products, novel modalities, or compressed development timelines requiring close coordination between CRO and sponsor teams.

Quality & Compliance

Operates under a formal quality management system comprising validated standard operating procedures (SOPs), controlled documentation protocols, and structured internal audit programs. All study-related data is managed in accordance with principles of data integrity—ensuring that raw data, electronic records, and final reports are attributable, legible, contemporaneous, original, and accurate (ALCOA-compliant). The quality infrastructure is maintained in a state of continuous audit readiness, consistent with the expectations of regulatory authority inspections under OECD, US FDA, and other applicable frameworks. Deviations and corrective actions are documented and tracked through a formal quality assurance function independent of study operations.

Accreditation & Regulatory Recognition

Vanta conducts studies in compliance with the OECD Principles of Good Laboratory Practice (GLP), a framework adopted by regulatory agencies across more than 40 member and non-member countries for the assessment of nonclinical safety data. GLP compliance ensures that data generated at the facility meets internationally recognized standards for study design, documentation, and reporting—enabling sponsors to submit nonclinical packages in support of INDs, NDAs, MAAs, and agrochemical registration dossiers with confidence in cross-jurisdictional regulatory acceptance. In parallel, the facility holds registration under the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), the statutory body under the Government of India responsible for oversight of animal research establishments. CPCSEA registration is a legal requirement for conducting regulated in-vivo studies in India and reflects the organization’s commitment to ethical animal care standards, including appropriate housing conditions, veterinary supervision, and institutional animal ethics committee (IAEC) oversight. Together, these two frameworks—OECD GLP and CPCSEA—provide clients with assurance that studies conducted at Vanta Bioscience are both scientifically credible and ethically compliant, satisfying requirements at the national and international regulatory levels.

 

 

Our Approach

Vanta Bioscience operates on the principle that reliable preclinical data is foundational to sound regulatory strategy and responsible product development. The organization’s commitment is to consistent, reproducible study execution—delivering results that sponsors can defend before regulatory reviewers and that accurately inform decisions at critical development junctures. Client relationships are built on transparency in scientific communication, proactive identification of study-related risks, and a collaborative working model that treats each program as a shared scientific and regulatory objective rather than a transactional engagement.

Why Work With Vanta

Vanta conducts studies in compliance with the OECD Principles of Good Laboratory Practice (GLP), a framework adopted by regulatory agencies across more than 40 member and non-member countries for the assessment of nonclinical safety data. GLP compliance ensures that data generated at the facility meets internationally recognized standards for study design, documentation, and reporting — enabling sponsors to submit nonclinical packages in support of INDs, NDAs, MAAs, and agrochemical registration dossiers with confidence in cross-jurisdictional regulatory acceptance.

Case studies​

FINANCE

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ENTERPRISE

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SECURITY

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