Product Release & Stability Programs
MRIGlobal provides scientifically-driven results in full compliance with regulatory requirements.
Our 75 years of success is built on a strong foundation of technical competence, communication, quality, and teamwork. Together, we achieve client objectives, continually assessing their parameters and goals. We provide stability study testing per International Council of Harmonization (ICH) guidelines for set temperature and humidity ranges, testing at requisite intervals with parameters specified by our client and based on the drug substance’s or product’s manufacturing conditions. Our stability chambers are mapped per cGMP guidelines and monitored for temperature excursions on a 24/7/365 basis.
MRIGlobal maintains a supply chain management repository and stability facility. Our space and equipment feature operational areas optimized for the functional activity and workflow specific to the drug agents being processed.
The MRIGlobal repository facility supports services necessary to maintain clinical drug agents, products, and specimens:
- GMP full-service repository — receipt, quarantine, test, release, store, aliquot, and ship
- On-site drug distribution license
- Worldwide distribution and cold chain management
Four decades of repository support for cGMP and non-GMP materials
In general, the background, education, and experience of MRIGlobal’s staff span a broad spectrum of scientific specialties, program management, managerial expertise, and comprehensive support capabilities. This diversity is advantageous in solving complex scientific problems for your program.