Merging Science, Compliance, and Decades of Biosimilar Expertise
Phase I clinical research is the foundation of every successful drug development program—determining a compound’s safety, pharmacokinetics (PK), and pharmacodynamics (PD) before moving forward into larger trials. At our state-of-the-art Phase I unit, located in the heart of a tertiary university hospital, we provide the ideal environment for conducting early-phase clinical trials with unmatched scientific rigor and regulatory compliance.
As pioneers in biosimilar clinical development, we bring over three decades of expertise in designing and executing PK/PD studies, ensuring the generation of high-quality, regulatory-compliant data for accelerated approvals.
Why Choose Our Phase I Clinical Research Unit?
Seamless Integration with a Leading University Hospital
- Immediate access to top-tier medical expertise → Our close collaboration with hospital specialists enables real-time patient monitoring and intervention if needed.
- Advanced diagnostic capabilities → Leverage state-of-the-art imaging, bioanalytical, and laboratory infrastructure.
- Regulatory-compliant clinical setting → All trials adhere to ICH-GCP, EMA, and FDA guidelines for the highest standards of patient safety and data integrity.
As pioneers in biosimilar clinical development, we bring over three decades of expertise in designing and executing PK/PD studies, ensuring the generation of high-quality, regulatory-compliant data for accelerated approvals.
Unrivaled Biosimilar Expertise – 30 Years of Leadership
Pioneers in biosimilar PK/PD trials – We have successfully conducted early-phase studies for leading biosimilar manufacturers, helping them navigate the complex regulatory pathways in the US and Europe.
Data-driven decision-making – Our robust bioanalytical capabilities and in-depth PK/PD modeling ensure accurate dose selection and clinical comparability.
High-Quality Data Delivery for Faster Regulatory Approvals
- Rapid study start-up & recruitment → Our proximity to a university hospital grants access to a diverse pool of healthy volunteers and patient populations.
- Comprehensive PK/PD data collection → Advanced biomarker analysis, pharmacokinetic modeling, and immunogenicity testing tailored to biosimilar regulatory requirements.
- Regulatory liaison support → We assist in preparing IND, IMPD, and biosimilar submission dossiers for seamless interactions with FDA, EMA, and MHRA.
Ready to Collaborate on Your Next Phase I Trial?
Partner with us to ensure your early-phase clinical research is efficient, compliant, and built for regulatory success. Our biosimilar-specialized PK/PD expertise positions us as the ideal partner for innovative biotech & pharmaceutical companies.
Let’s discuss your next trial! Schedule a consultation today.
