New name reflects years of strategic growth. According to Raymond Colton, founder and president, the name VR Analytical (vranalytical.com) better reflects the expanded services the company offers as a result of significant growth over the last few years.
Based in Bend, VR Analytical specializes in providing extractables and leachables testing on single-use components and final packaging materials produced by bio/pharmaceutical and medical device manufacturing companies regulated by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
VR Analytical is a contract research organization (CRO) that is expert in qualifying materials for use in bio/pharmaceutical manufacturing. The company specializes in designing and performing studies to characterize organic and inorganic chemical entities that may be extracted from materials used in the manufacture, storage, and delivery of pharmaceuticals. Expert identification of potential leachables is necessary to achieve patient safety and to minimize potential delays in regulatory approval.
VR Analytical provides services to bio/pharmaceutical and medical device manufacturers all over the world. Specific extractables and leachables services include consultation, materials assessment, study design, controlled extractions, characterization of extractables, toxicology assessment and leachables methods. The company also provides testing in the following areas: elemental analysis, organic analysis, and accurate mass analysis.“After 12 years of investing in advanced instrumentation, expanding the facility, and hiring top scientists, our niche as a cGMP-compliant analytical laboratory specializing in extractables and leachables studies has led to heightened awareness of our services,” said Colton.
“We think VR Analytical retains the name recognition Validation Resources has earned in the industry, but is more specific about our expertise in analytical testing for bio/pharmaceutical companies and medical device manufacturers that need to identify potential risks from extractables and leachables.” According to Colton, extractables and leachables testing is more important than ever as bio/pharmaceutical companies increasingly switch to polymeric single-use manufacturing materials.
While there are many advantages to single-use materials, the possibility of compounds leaching into the final drug product requires that a material assessment and evaluation of extraction be performed to evaluate potential leachables that could impact the safety or efficacy of drug products.
He also emphasized that there is no change in ownership and that VR Analytical will continue to operate from its facilities at 63020 NE Lower Meadow Drive, Bend, Oregon, 97701. info@vranalytical.com or 541-388-1253. www.vranalytical.com.
