Products, services, reviews and techniques used in pharmaceutical product scale-up, formulation, shipping and manufacturing processes.
As study protocols become more complex, so too does the need to have an in vivo model that specifically fits your study design. Charles River offers customized animal preconditioning that is tailored to your research requirements. Whether you need an animal that has been surgically altered, fed a specialized diet or reared to a specific age, we can deliver study-ready animals right to your door, when and where you need them.C…
Envirotainer presents the latest addition to our portfolio of active temperature-controlled air cargo containers. Designed for the most extreme requirements of the healthcare industry, the RAP e2 container maintains product temperatures between ±0 and +25°C in nearly any ambient condition appearing along shipping routes globally.The container handles any chosen set temperature, including the most commonly required in the cold…
Drawing on the benefits of the shape and size of the Envirotainer dry-ice container, the RKN e1 uses a different technology: compressor cooling and electric heating. Designed for the extreme requirements of the healthcare industry, the RKN e1 container maintains product temperatures in the +2 to +8°C range, in the controlled room temperature (+15 to +25 °C) range or at any chosen set temperature within the operating range of…
Get started in healthcare transports or share knowledge and become better at what you do. A dedicated team of specialists is there to provide you with solutions and services that strengthen and extend your business. Envirotainer provides valuable additional services, including laboratory testing, qualification and validation support, data collection and reporting services, and the Qualified Envirotainer Program (QEP)…
Your product development plans deserve the best integrated program of research services available - so choose Covance. With pressure to substantially increase numbers of trial participants, increased scrutiny on product safety and stringent regulatory controls throughout the world, Covance is ready to partner and bring to the fore the expertise, resources and insight required to guide you through the complex and challenging c…
Total flexibility. Covance's Clinical Development services are customized to your specific needs. The stakes are high as your drug enters clinical development in Phase II-III. With your drug’s future on the line, you need to navigate a global maze of patient populations, practice patterns and regulatory requirements, often also languages and time zones, before the goal of regulatory approval is in sight. It’s challenging and…
Superior Regulatory Service Helps Transform Your Clinical Trials. Strong regulatory strategies are pivotal in getting products to market. While many countries’ drug regulations are similar, there are still significant differences. These similarities and differences are the basis of a global regulatory strategy that encompasses the needs of all regions. Serving you where you need to be, our Regulatory Affairs teams are located…
A mutation occurred in a colony of outbred Zucker rats in the laboratory of Dr. Walter Shaw at Eli Lilly Research Laboratories in Indianapolis, IN in 1974–75. Part of this colony containing the mutation was moved to Indiana University Medical School (IUMS), to the laboratory of Dr. Julia Clark in 1977. Several groups of animals with diabetic lineage were identified and rederived in 1981. Inbreeding of selected pairs from this…
ProBioGen holds a manufacturing authorization for GMP (Good manufacturing practice) compliant manufacturing and batch release of biotechnological drug substances and fulfills all present regulatory requirements by EMA and FDA. GMP Manufacturing Services include: Manufacturing of pre-clinical and GMP grade material Disposable bioreactor Technology, stirred tank bioreactors - Decreased risk of cross contamination - Reduce…
Stable, High-Yield Mammalian Producer Cell Lines. ProBioGen's in-house cell line engineering platform enables them to provide our clients with pharmaceutical producer clones that exceed the limits of the current industrial standard, while still supporting a royalty-free fee-for-service business model.ProBioGen have built a fully integrated technology platform that encompasses the key actuating variables: Host Cell Line, Vecto…
