top of page
map.jpg
Regulatory Affairs & Submission Support

What This Service Include

  • End-to-end regulatory strategy

  • Submission to JFDA, SFDA, EMA, USFDA, GCC, MENA

  • Biosimilars & biologics-specific regulatory pathways

  • Audit readiness & inspection support

  • 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

photo-1606206886378-e49a19ad0933.jpeg

Protocol Writing and Design.

photo-1581594549595-35f6edc7b762.jpeg

  CRF Design

 ICF Translation

shutterstock_1743496937.jpg

Statistical analysis via Kinetica TM

and SAS

data management.png

  Final Reports

photo-1542736667-069246bdbc6d_eidted.jpg

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.

If you would like to learn more about our services

or for any inquiries contact us below

bottom of page