
Regulatory Affairs & Submission Support
What This Service Include
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End-to-end regulatory strategy
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Submission to JFDA, SFDA, EMA, USFDA, GCC, MENA
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Biosimilars & biologics-specific regulatory pathways
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Audit readiness & inspection support
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ICF translation & local regulatory compliance
What Sets Us Apart
Years in
the market
Over 26 years in the market.
Healthy
volunteers
Over 10000 healthy volunteers.
Studies Conducted
Over 1200 Studies Conducted.
Validated
assays
Over 300 validated
assays.
Our Services Include

Protocol Writing and Design.

CRF Design
ICF Translation

Statistical analysis via Kinetica TM
and SAS


Final Reports

Sample Size Estimation and Randomization
Our Quality Guarantee
At JCPR, quality is the foundation of every study we conduct. We maintain a comprehensive and rigorously implemented Quality Management System built on carefully developed Standard Operating Procedures (SOPs) that address every aspect of our operations—clinical conduct, bioanalysis, safety, documentation, data integrity, storage, and reporting. Each process is designed to meet and exceed ICH-GCP, GLP, EMA, JFDA, and other international regulatory requirements.
Our team undergoes continuous specialized training covering equipment operation, analytical procedures, documentation standards, and report generation to ensure consistent, reproducible, and reliable results.
For nearly three decades, JCPR has invested heavily in strengthening its quality systems, prioritizing the well-being of our staff and volunteers while maintaining seamless study execution that aligns with national and international guidelines. As one of the few fully independent CROs in the region, we operate without external shareholders or investor pressure. This independence enables complete transparency, integrity, and ethical conduct, and allows us to reinvest the majority of our resources into operations, quality assurance, bioanalysis upgrades, and senior oversight.
At JCPR, quality is not just a requirement—it is a long-standing commitment embedded in every phase of our work.


