Meeting the highest standards makes all the difference
CSI serves communities and makes a difference to people’s lives by supplying safe and ethically sourced medications to clinical trials across the world. Maintaining compliance with global sourcing regulations and logistics is an essential part of meeting the highest standards of quality and safety.
Expert regulatory advice
Sourcing and distributing medicines and medical devices globally requires extensive knowledge of regional regulations that differ from country to country. CSI’s regulatory and quality assurance experts have longstanding relationships with the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and provide advice and solutions for your clinical trial supply requirements.
Country-specific regulatory expertise
Highest standards of quality and safety
Relationships with regulatory agencies
Independent quality department
Four areas in which we excel:
Independent quality department
At CSI, we pride ourselves on our robust quality assurance processes that guarantee the quality of every product we supply to your clinical trial. Our independent and well-established quality department ensures regulatory compliance across all our processes and all territories in which we operate around the world.
We are fully compliant with
Falsified Medicines Directive (FMD)
Good Distribution Practice (GDP)
Good Manufacturing Practice (GMP)
Good Storage Practice (GSP)
We can provide
Certificates of Analysis (CofAs)
Batch Release Certificates (BRCs)
Statements of Authenticity (SofAs)
Proactive supply chain management
Early sourcing of a comparator drug ensures that a reliable and compliant clinical supply chain can be established. By conducting thorough and proactive quality control checks throughout the entire supply chain, CSI identifies and mitigates any quality issues before they come to fruition.
Our global scientific expertise and depth of regulatory knowledge allows us to foresee potential roadblocks in the supply chain so we can resolve issues in a timely and efficient manner, minimising risk while ensuring compliance.
CSI’s four guarantees of quality
Timeliness of medicine supplies
Consistency and reliability of investigational medicines
Traceability throughout our supply chain
Comprehensive documentation and record-keeping
We operate with transparency and accountability, so you can always rely on our quality standards and operating procedures. Since documentation is often necessary for import and export purposes, all our products are delivered certified.
Quality is in our DNA
We understand that our robust standard operating procedures (SOPs) and quality-focused operations are as important to our success as our market knowledge, international networks and longstanding relationships with global suppliers and manufacturers. Our teams stay up to date with the latest regulatory developments across the globe and regularly implement changes necessary to stay compliant with the latest local government and regulatory agency requirements.
We have stringent processes in place for our suppliers, manufacturers, authorised distributors and pharmaceutical wholesalers. We work directly with biopharmaceutical companies and have a long-established global network of over 100 audited suppliers spanning six continents, all of which maintain strict board requirements and guidelines from jurisdictions around the world to ensure regulatory compliance, quality and patient safety.
Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements