---
name: BioAgile Therapeutics
slug: bioagiletherapeutics
site: cro
website_domain: bioagiletherapeutics.com
summary: ISO 9001:2015-certified CRO offering end-to-end clinical research services including Phase I–IV trials, medical writing, biostatistics, data management, and regulatory support across pharmaceuticals, nutraceuticals, devices, and biotech. Headquartered in Bangalore, India.
tagline: India's agile, full-service CRO for compliant, customized clinical research solutions.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: IN
tier2_domain_verified: false
updated_at: 2026-08-23T07:05:43.376Z
services_count: 10
modalities_count: 0
indications_count: 0
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# BioAgile Therapeutics

India's agile, full-service CRO for compliant, customized clinical research solutions.

Listed on cro.directory.

## Summary

ISO 9001:2015-certified CRO offering end-to-end clinical research services including Phase I–IV trials, medical writing, biostatistics, data management, and regulatory support across pharmaceuticals, nutraceuticals, devices, and biotech. Headquartered in Bangalore, India.

## At a glance

- HQ country: IN

## Services

- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Clinical Operations
- Data Management & eClinical
- Biostatistics & Statistical Programming
- Medical Writing
- Regulatory Affairs
- Pharmacovigilance & Drug Safety

## Locations

- Headquarters, Bangalore, Karnataka, India

## Certifications

- CDSCO; Identifier: CRO/KA/2026/000173; Source: https://bioagiletherapeutics.com/about
- ISO; Identifier: ISO 9001:2015; Source: https://bioagiletherapeutics.com/about

## Long description

## Overview

BioAgile Therapeutics is a privately-owned, full-service Clinical Research Organization (CRO) headquartered in Bangalore, India, with 15+ years of experience delivering clinical research solutions to Indian and global sponsors.

## Regulatory & Quality

- **CDSCO Approved CRO** (Registration No. CRO/KA/2026/000173) under the Central Drugs Standard Control Organization, Government of India
- **ISO 9001:2015 Certified** Quality Management System
- **ICH-GCP Aligned** operations
- **21 CFR Part 11 Compliant** electronic records management

## Core Services

- **Clinical Trials:** Phase I to Phase IV, post-marketing surveillance (PMS)
- **Regulatory & Compliance:** Regulatory submissions, ICH-GCP guidance, submission-ready documentation
- **Data & Analytics:** Clinical data management, biostatistics, clinical quality assurance
- **Medical & Scientific:** Medical writing, safety assessment, efficacy evaluation, label claims substantiation
- **Specialized Studies:** BA/BE studies, preclinical services, biotech support (biosimilar development, cell line studies)

## Industry Expertise

Serves pharmaceuticals, nutraceuticals, cosmeceuticals, medical devices, software as a medical device (SaMD), biotechnology, Ayurvedic & herbal products, and veterinary sectors.

## Engagement Model

Offers flexible resource models (onsite, offshore, hybrid) with dedicated project managers, direct team access, and integrated collaboration with central labs, regulatory affairs, and supply partners. Trusted by 100+ clients, supported by 10,000+ volunteers and 30+ scientific publications.

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_Profile last updated: 2026-08-23T07:05:43.376Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.