Regulatory
Scientific advice meeting
Product development strategy and planning
CTA documentation review
Phase 1 to 3 studies
Cell and gene therapy
Training
Bespoke training can be provided to suit your needs
IMP manufacturing and sourcing
Trial drug management at site
GMP for IMPs
CTA submissions
Pharmacy set up processes
Technical
Vendor selection strategy
Quality Agreements with manufacturers
GMP auditing
SOP writing/reviews
IMPD reviews
QC testing requirements
Stability study protocol for IMPs
Expertise
Phase 1 to 3 clinical trials
Regulatory strategy
From First-in-Human to repurposing of marketed products, ctimpsolutions can assist you with the regulatory strategy for ensuring compliance with GMP oversight and clinical trial regulations
Investigational Medicinal Products
Expert consulting
Assistance with all IMP management aspects of clinical trials from manufacturing advice, supply chain mapping and site set up processes
Founder
CTIMPSOLUTIONS is founded by Yusuf Jaami who is a regulatory IMP specialist with over 10 years of experience across pharma, NHS and academia
Yusuf Jaami
MPharm, MSc ATMPs
Founder
Ctimpsolutions is a clinical trials consultancy founded by Yusuf Jaami who specialises in providing IMP support across phase 1 to 3 studies. He leverages on his experience gained within manufacturing and regulatory environment in pharma, NHS and academia to support clinical trial sponsors, CROs and R&D. He has provided specialist IMP support for complex products such as ATMPs and other biologics from early engagement with the regulators, CTA document review and site pharmacy set up processes.
Contact us
E-mail:
info@ctimpsolutions.com
yusuf.jaami@ctimpsolutions.com
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© 2019