Biotechnology
- Preclinical and clinical evaluation of biotherapeutics
- Biosimilar development support
- Cell line and genetic engineering studies
- Regulatory submissions for biotech products
Advancing Biologics, Biosimilars & Cell Therapy Clinical Development
Biotechnology continues to shape the future of medicine, driving breakthroughs from gene-based therapies to next-generation biologics. As biotech companies expand their role in global healthcare innovation, partnering with the right CRO becomes essential to bring these discoveries to patients efficiently and safely.
BioAgile Therapeutics work closely with biotechnology companies in a collaborative and transparent environment, supporting every step of the clinical journey starting from study design to regulatory approval and conduct of the study with flexibility, scientific insight, and advanced technology.
Expertise you can rely on
Deep Scientific Understanding
End to End clinical development
Immunogenicity and Biomarker Expertise
Regulatory and Safety Oversight
Data Driven Excellence
Advancing Innovative Therapies with BioAgile
Cell and gene Therapy
Gene and cell therapies including gene-modified cells, CAR-T and other advanced biologics are individualized, life-changing treatments for diseases that were previously incurable. It is at the forefront of customized medicine, providing treatments for ailments that were previously incurable. BioAgile Therapeutics can support you in designing and executing IND-enabling studies, managing first-in-human trials, optimizing dosing and delivery strategies, and ensuring compliance with complex regulatory requirements. We provide end-to-end support, from preclinical development to long-term post-marketing follow-up, helping you bring advanced therapies to patients safely and efficiently.
Biosimilars
Biosimilars are cost-effective alternatives to innovator biologics, offering comparable therapeutic benefits and improving patient access. Their development emphasizes analytical characterization to demonstrate similarity to the reference product, while clinical trials focus on pharmacokinetics, pharmacodynamics, and immunogenicity. BioAgile Therapeutics can support you across the full development pathway, including IND submissions, Phase I–III trials, and Biologics License Application (BLA) preparation, providing comprehensive support on manufacturing, nonclinical and clinical data, and regulatory compliance.
Speciality generics
Specialty generics encompass complex or niche drug formulations that require careful clinical evaluation and regulatory oversight. These products may involve challenging delivery systems, modified-release mechanisms, or specialized dosage forms. BioAgile Therapeutics can support you in conducting bioequivalence and pharmacokinetic studies, optimizing formulations, performing stability assessments, and preparing ANDA submissions, ensuring regulatory compliance, robust clinical evidence, and timely market access for your complex or specialized generic products
Comprehensive Development Support
Keeping in mind the unique requirements of biologics, BioAgile Therapeutics is your trusted partner from IND submission to Phase III trials. We provide end-to-end support to ensure efficient, compliant, and high-quality execution for innovator biotech products.
International Market Access Support – Regulations Guidance
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