Global Quality Assurance
Embedding Quality into Our Clinical Trial Supply Solutions
At CalCog, quality is at the heart of everything we do. Our company was designed around quality, and we proactively embed quality into every service, program, and activity.
Our Quality Assurance
- Electronic, harmonized Quality Management System
- GMP-, GDP-, and GCP-compliant
- Robust internal processes combine industry best practices and FDA, EMA, MHRA, and ICH requirements
- Continuous improvement
- Robust vendor management
- Proven compliance record
Our Commitment to Quality
CalCog is committed to providing safe and effective healthcare products and services in pursuit of global health innovations and advancements.
Patients and innovative healthcare solutions can’t wait; that’s why innovators and CROs turn to CalCog’s reliability and dedication to quality assurance within our GMP facilities and each of our depots worldwide.
USA GMP Facility Licenses and Registrations:
State of Texas:
- Wholesale Distributor Prescription Drugs
- Device Manufacturer
Drug Enforcement Agency (DEA):
- Importer Registration Certificate – Schedules I through V
- Exporter Registration Certificate – Schedules II through V
- Manufacturer Registration Certificate – Schedules I through V
- Distributor Registration Certificate – Schedules I through V
UK GMP Facility Licences and Registrations:
Medicines & Healthcare products Regulatory Agency (MHRA):
- Wholesale Distribution Authorisation – WDA(H)
- Manufacturer’s Authorisation – Investigational Medicinal Products – MIA(IMP)
- Manufacturer’s/Importer’s Licence – MIA
- Manufacturer’s “Specials” Licence – MS
Home Office – UK Controlled Drug Licence:
- Schedule 2 – possess and supply
- Schedule 3 – possess and supply
- Schedule 4 (part 1 and part 2) – possess and supply
- Schedule 5 – supply
Contact Us to Learn More About Our Quality Assurance Program.
Would you like to learn more about our commitment to quality and our Quality Management System?