Full-Service Pharmaceutical Clinical Trial Organization & Drug Development CRO
- Phase I to IV
- Regulatory Submission
- Post Market Surveillance
At BioAgile Therapeutics, our goal is to promote pharmaceutical innovation through the ethical and scientifically sound conduct of clinical research. Our diverse team brings scientific depth, regulatory understanding, and operational agility to every project, ensuring high-quality, compliance, and effective outcomes across all four clinical stages (Phase I–IV) of the drug development process.
With a solid track record of conducting clinical trials in all four phases, including First-in-Man (FIM) studies in patients and healthy volunteers, BioAgile provides pharmaceutical developers with end-to-end clinical development solutions. Our expertise encompasses clinical trial design, patient recruitment, data management, and quality control, ensuring adherence to good clinical practice (GCP) guidelines and regulatory requirements.
Therapeutic Area Expertise
Regulatory Pathway Expertise
BioAgile offers comprehensive assistance throughout all clinical stages, guaranteeing that research is carried out in compliance with international regulatory standards and good clinical practice. Our services include:
- Preparation and submission of IND, CTA, NDA, and BLA applications in collaboration with regulatory authorities.
- Phase I trial submissions to DCGI and other regulatory bodies.
- Coordination of ethics committee approvals, regulatory notifications, and safety reporting.
- CTD/eCTD dossier preparation for global submissions, ensuring sponsor’s contracted CRO meets all regulatory requirements.
Technology & Innovation Integration
Trusted By
Proceed to the Next Phase of Drug Development
- We can assist you with the planning of development plans, pivotal trials, or early clinical investigations involving human subjects.
- Outline risk-mitigation techniques and discuss your development strategy to ensure oversight and compliance.
- Evaluate the feasibility of the study using empirical trial data and investigator input.
- Examine the readiness of submissions for regulatory filings, ensuring alignment with sponsor’s responsibilities and regulatory requirements.
To find out how BioAgile can accelerate your drug development process while maintaining quality, compliance, and confidence, get in touch with us right now.