BioAgile Therapeutics Private Limited is a CDSCO-registered, ISO 9001:2015 certified contract research organisation (CRO) based in Bengaluru, India. The answers below cover who BioAgile Therapeutics is, the clinical and preclinical services it provides, how clinical research is regulated in India, and how sponsors work with the team. For anything not answered here, contact info@bioagiletherapeutics.com or 080 4375 4520.
About BioAgile Therapeutics
What is BioAgile Therapeutics?
BioAgile Therapeutics Private Limited is a contract research organisation (CRO) headquartered in Bengaluru, India, that runs clinical and preclinical studies on behalf of product developers. BioAgile Therapeutics is CDSCO registered and ISO 9001:2015 certified, with more than 15 years of research experience, 500+ projects delivered and 100+ global clients. Its work spans Phase I–IV clinical trials, preclinical research, BA/BE studies and post-marketing surveillance. More detail is available on the About Us page.
Is BioAgile Therapeutics CDSCO approved?
Yes. BioAgile Therapeutics is registered with the Central Drugs Standard Control Organisation (CDSCO) under Registration No. CRO/KA/2026/000173. CDSCO is India’s national regulatory authority for drugs and clinical trials, and registration is a prerequisite for any CRO conducting regulated studies in the country. BioAgile Therapeutics delivers its clinical research services in line with the New Drugs and Clinical Trials Rules, 2019 and ICH-GCP.
Is BioAgile Therapeutics ISO 9001:2015 certified?
BioAgile Therapeutics holds ISO 9001:2015 certification for its quality management system, alongside CDSCO Registration No. CRO/KA/2026/000173. ISO 9001:2015 sets requirements for documented processes, corrective action and continual improvement, which BioAgile Therapeutics applies across study conduct, documentation and reporting. Day-to-day compliance is monitored by the clinical quality assurance function through SOP checks, risk-based monitoring and internal audits.
Where is BioAgile Therapeutics located and what are its working hours?
BioAgile Therapeutics is located at #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Dollars Colony, Bengaluru 560094, Karnataka, India. The office is open Monday to Saturday, 09:30 to 18:00 IST. Enquiries can be sent to info@bioagiletherapeutics.com or made by telephone on 080 4375 4520. Directions and an enquiry form are on the Contact Us page.
Services and scope
What is a CRO and what does a CRO do?
A contract research organisation (CRO) is a specialist provider that designs, conducts and reports research studies on behalf of a sponsor, typically a pharmaceutical, nutraceutical, cosmeceutical or biotechnology company. A CRO supplies protocol design, site management, monitoring, data management, biostatistics, medical writing and regulatory expertise that the sponsor would otherwise build in-house. BioAgile Therapeutics operates as a CRO across clinical research services, preclinical services, efficacy evaluation and label claims substantiation.
Which clinical trial phases does BioAgile Therapeutics conduct?
BioAgile Therapeutics conducts Phase I, Phase II, Phase III and Phase IV clinical trials. Phase I assesses safety and tolerability in a small group, Phase II examines efficacy and dose selection, Phase III confirms efficacy in larger populations, and Phase IV monitors a product in real-world use after approval. All four are delivered through the clinical trials (Phase I to Phase IV) service, supported by 500+ principal investigators and 300+ sites.
What preclinical services does BioAgile Therapeutics offer?
BioAgile Therapeutics offers preclinical services covering ADME profiling, GLP toxicology, pharmacodynamics and safety pharmacology, delivered through in vitro assays, animal models and advanced imaging. These non-clinical studies build the safety and pharmacology data package a sponsor needs before first-in-human research begins. The full scope is described on the preclinical services page, and the findings feed directly into safety assessment work supporting regulatory submissions.
What is a BA/BE study?
A bioavailability/bioequivalence (BA/BE) study measures how much of a drug reaches systemic circulation and whether a test formulation performs equivalently to a reference product, using pharmacokinetic endpoints such as AUC, Cmax and Tmax. BioAgile Therapeutics conducts BA/BE studies using crossover or parallel-arm designs to support generic and reformulated products. Study duration depends on the molecule, the washout period and the number of subjects enrolled. See BA/BE studies.
What is post-marketing surveillance?
Post-marketing surveillance is the ongoing monitoring of a product’s safety and performance after it reaches the market, using spontaneous adverse-event reporting, active data mining, patient registries and risk-based trend analysis. BioAgile Therapeutics runs post-marketing surveillance programmes to detect emerging safety signals and trigger timely corrective action, keeping sponsors aligned with Indian regulatory expectations. The full scope is set out on the post-marketing surveillance page.
Does BioAgile Therapeutics provide medical writing, biostatistics and clinical data management?
Yes. BioAgile Therapeutics provides medical writing, biostatistics and clinical data management within its clinical research services. Medical writing covers protocols, clinical study reports and regulatory dossiers; biostatistics covers the statistical analysis plan, sample-size calculation and analysis; data management covers case report form design through to database lock. Each function can be contracted individually or as part of a complete study.
Regulatory and compliance in India
How is a clinical trial approved in India?
A clinical trial in India requires permission from the Central Drugs Standard Control Organisation (CDSCO) and approval from a registered ethics committee before the first participant is enrolled, followed by registration on the Clinical Trials Registry – India. The sponsor submits the protocol, investigator’s brochure, informed consent documents and product manufacturing details. BioAgile Therapeutics prepares and manages these submissions through its regulatory support service.
What are the New Drugs and Clinical Trials Rules, 2019?
The New Drugs and Clinical Trials Rules, 2019 are the Indian regulations governing clinical trials, bioequivalence studies, ethics committees and new drug approvals. They set CDSCO review timelines, ethics committee registration requirements, compensation for trial-related injury, and the responsibilities of sponsors and investigators. BioAgile Therapeutics designs and conducts every regulated study under these Rules, with documentation handled by its regulatory support team.
What is Schedule Y?
Schedule Y is the schedule to the Drugs and Cosmetics Rules that historically set out requirements for clinical trial permission, phase definitions, investigator responsibilities and data submission in India. Much of its scope now sits within the New Drugs and Clinical Trials Rules, 2019, though Schedule Y remains the reference point many sponsors still use. BioAgile Therapeutics prepares protocols and dossiers to meet these requirements across its clinical research services.
Does a clinical trial in India need ethics committee approval?
Yes. Every clinical trial conducted in India must be reviewed and approved by an ethics committee registered with CDSCO before enrolment begins, and that committee continues to oversee the study through periodic progress reports and safety reporting. BioAgile Therapeutics prepares ethics committee submissions, responds to queries and maintains ongoing reporting as part of study conduct and clinical quality assurance.
Does BioAgile Therapeutics follow ICH-GCP, and how is informed consent obtained?
BioAgile Therapeutics conducts studies aligned to ICH-GCP, the international Good Clinical Practice standard for designing, conducting, recording and reporting trials involving human participants. Under ICH-GCP and Indian rules, written informed consent must be obtained from every participant before any study procedure, in a language the participant understands, with an explicit right to withdraw at any time. Audio-visual consent recording applies to specified categories of trial in India.
Working with BioAgile Therapeutics
How do I start a project with BioAgile Therapeutics?
To start a project, contact BioAgile Therapeutics at info@bioagiletherapeutics.com or 080 4375 4520, or submit the form on the Partner with BioAgile page. A typical engagement opens with a scoping discussion covering the product, indication, intended regulatory pathway and target timelines, followed by a confidentiality agreement, a feasibility review of sites and investigators, and a written proposal setting out scope, study design and deliverables.
What engagement models does BioAgile Therapeutics offer?
BioAgile Therapeutics works both as a full-service CRO, running a study end to end, and as a functional service provider supplying individual functions such as biostatistics, medical writing, clinical data management or monitoring alongside a sponsor’s own team. Delivery can be arranged onsite at the sponsor’s facility, offshore from Bengaluru, or as a hybrid model, depending on internal capacity and oversight preferences.
Will BioAgile Therapeutics sign a confidentiality agreement or NDA?
Yes. BioAgile Therapeutics signs a mutual confidentiality agreement or NDA before detailed product information, formulations or draft protocols are exchanged, and confidentiality obligations continue through the master services agreement and each individual work order. Sponsor data, study documents and study results remain the property of the sponsor. Requests can be sent to info@bioagiletherapeutics.com or raised through the Contact Us page.
Data, quality and safety
How does BioAgile Therapeutics manage clinical trial data?
BioAgile Therapeutics manages clinical trial data from case report form design through data entry, validation, query resolution and medical coding to database lock. Database lock is the point at which a cleaned dataset is frozen so statistical analysis can begin, after which no change is made without a documented, authorised process. Electronic records are handled in line with 21 CFR Part 11 requirements. See clinical data management.
How are adverse events reported during a clinical trial?
BioAgile Therapeutics records every adverse event reported during a study and escalates serious adverse events to the sponsor, the ethics committee and CDSCO within the timelines set by the New Drugs and Clinical Trials Rules, 2019. Investigators assess causality and severity, and cumulative safety data is reviewed throughout the study. Signal detection continues after approval through post-marketing surveillance.
How does BioAgile Therapeutics handle quality assurance and audits?
BioAgile Therapeutics operates an ISO 9001:2015 certified quality management system supported by a dedicated clinical quality assurance function that performs SOP compliance checks, risk-based monitoring, internal audits and investigator site audits. Sponsors may audit BioAgile Therapeutics processes and study documentation directly, and regulatory inspections are supported with source documents, trial master file records and complete audit trails.
How does BioAgile Therapeutics protect participant data under the DPDP Act, 2023?
BioAgile Therapeutics handles participant data in line with India’s Digital Personal Data Protection Act, 2023, which governs processing of digital personal data and sets obligations for consent, purpose limitation, security safeguards and breach notification. Participant records are pseudonymised using subject identification codes, system access is role-restricted, and electronic records follow 21 CFR Part 11 controls for audit trails and electronic signatures.
