EUROLABWith its expert team and state-of-the-art laboratories, it offers comprehensive testing for pharmaceutical manufacturers and distributors throughout the quality control, design, research and development stages of drugs.
Our pharmaceutical testing services include preservation effectiveness (trial testing) to assess adequacy against microbial contamination; stability test to determine storage conditions and shelf life; and extractable and leaky studies.
We also develop and implement validation protocols to document method compliance. These include method validation studies and transfer method protocols and cleaning validation methods.
Our experienced scientists determine the best and most cost-effective test for your pharmaceutical products.
EUROLAB Its laboratories are ISO 17025 accredited, ISO 9001 quality management system certified and GMP compliant. Additionally, it is licensed by the Greek National Organization for Medicine (EOF) for microbiological testing of pharmaceutical preparations for human and animal use.
EUROLAB has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of tests to support your internal quality processes, including: sterility (USP 71) testing in a clean room for isolator media, testing for particles (USP 787, 788) using a variety of methods, bacterial endotoxin, filter verifications, container closure integrity and USP compulsory test. We have the expertise to test whether the product has been terminally sterilized with Gamma, e-beam or EO.
Additional analytical services specialized for the pharmaceutical and biopharmaceutical industry include: stability testing, E / L, Impurities and heavy metals. Quality control of APIs, starting material, intermediates, finished products, impurities and spoilage products.
We can help support your facility with environmental and water system testing and verify cleanroom cleanliness. We can help you evaluate aseptic processing alternatives with a variety of terminal sterilization methods.
EUROLAB It has dozens of expert scientists, technicians and technical teams who have performed more than 400 rigorous tests. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.
We offer a wide variety of material evaluations using chemical characterization, in vivo and in vitro testing services to meet US FDA, EU CE marking Japan MHLW and other international requirements.
Our approach combines technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, and all combined with a customized approach to our customers.
Sterilization Validation is designed to help develop a sterilization process that provides the manufacturer with the appropriate level of sterility assurance and ensures repeatability for each product type developed.
Most tests follow the United States or European Pharmacopoeia (USP or EP) and similar international standards. Sterilized medical device standards are also found in ISO, AAMI and ASTM guidance documents.
Our services include consulting, package verification, material qualification and package development.
EUROLAB, offers a range of services to assess these manufacturing environmental conditions, in addition to water system verifications, raw material screening, and residual manufacturing material testing.
EUROLAB, with its highly expert team and internationally accredited laboratories, Pharmaceutical Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.