A wide range of ICH conditions of walk in/reach in chambers, refrigerated and freezer storages which are fully controlled and monitored. 24 hour alarm system is on site, along with a dedicated team trained to respond to any deviations from the set storage conditions. A validated computerised system is used for data management and results evaluation.
Our analytical laboratory is GMP certified and offers the service of analysis that meets regulatory requirements worldwide.
- A wide range of analytical technologies are available: (HPLC/UPLC - UV;PDA;RI detectors, GC, IC, UV/VIS, TOC, Dissolution, FT-IR, Karl Fisher volumetric and coulometric, pH, Relative density, Refractive Index meter, Osmolality, Viscosity, Heparin assay testing; Particle and droplet size.
- Microbiology testing services are also available including: Microbiological Limits testing; Presence/Absence of Pathogens; Sterility testing; LAL testing; Identification of microorganisms.
We offer the service of batch certification for sale or supply by our Qualified persons (QP) as per Directive 2001/83/EC, Annex 16
Our Supplier Management System ensures that materials and services we use meet our quality standards, as well as the ones requested by our partners.