Our team of registered professional engineers' and designers' experience includes the design, construction and value engineering for life sciences and advanced technology facilities, along with associated site related structures. Whether a new build, an addition or a retrofit, our structural staff can support your project from inception through permitting and construction. At CRB, we utilize a collaborative approach with the project team and Owner to provide a successful design solution that is efficient, practical and cost-effective.
FSMA is the most sweeping reform of food safety laws in 60 years, requiring a top-down approach to hazard prevention. Your facility and processing, your personnel practices and training, and your supply chain must be in compliance with FSMA regulations. A wide range of safety initiatives is being put into effect to protect consumers. To avoid mandatory food recalls you must correctly implement Preventative Controls. This guide will help you prepare for and comply with FSMA regulations.
Secure your safety document distribution.
Intralinks provides sponsors with an automated and intelligent distribution solution for delivering critical safety-related information in real time to non-regulatory stakeholders, such as investigators, institutional review boards (IRBs) and ethics committees (ECs), with actionable compliance insight for both the safety team and site monitors.
PharmaCM is a clinical trial disclosure platform designed specifically for the regulated environment of Life Sciences. PharmaCM is used to manage the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data. Disclosure content is very dynamic. Clinical trial data is constantly being updated, modified and formatted for specific registries such as ClinicalTrials.gov and EudraCT.
By Brandy Sargent, Editor In Chief, The Cell Culture Dish
This article was originally published on the Downstream Column, May 17, 2017 and is reprinted here with permission - https://downstreamcolumn.com/cool-tools/pre-activated-resins-ligand-immobilization-facilitate-creation-customized-affinity-purification-media/
In the development of biopharmaceuticals there are times when an off the shelf affinity chromatography medium is unavailable or isn't highly selective for the target molecule being purified. It is possible then to design a custom chromatography solution by coupling a specific ligand to a pre-activated resin.
Christopher Perry, Loss Prevention Operations Manager with U.S. clothing retailer Charlotte Russe, remembers the sinking feeling he used to get when he’d log in to a video surveillance system in search of video evidence only to discover that the system was down.
What are the things that high-performing clinical research sites do that make sponsors return to them again and again?
Site selection and ensuring that sites are performing up to par are crucial parts of a study. Read how a CRO facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits.
The Detour Lake deposit is Canada’s largest undeveloped pure gold reserve, and is located approximately eight kilometers west of the Ontario-Québec border, 180 kilometers northeast of Cochrane, Ontario. Gold production at the site began in early 2013 and production at the mine is expected to grow over time.
This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics to craft the best clinical supply management strategies for their multiple, complex clinical trials.
With an array of services designed to make buildings more energy efficient, safer, and easier to maintain, C&C Group needed a solution to better manage their mobile workforce. C&C’s CIO, Chad Cillessen, knew that some of their existing processes were less than optimal, especially around work order entry and time entry for their 58 field technicians.
Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.
WALDNER solves a packaging challenge for a global pharmaceutical company with an ingenious filling and sealing machine.
Instead of focusing on FDA-regulation as the driving force in product development, compliance should instead be an outcome of a streamlined process that ensures a safe and reliable product is delivered to market. Achieving compliance, and creating the documentation, is an outcome of the focus and rigor required for regulated product development. This article discusses how Jama Software can simplify FDA processes by improving development and production.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
Food inspection, in connection with automated sorting and classification methods has become a major field of application for advanced image capture systems and infrared cameras. This case study tells how Xenics' line scan SWIR camera Lynx is used for copmlex imaging tasks.
HRWARE delivers innovative technology solutions to simplify day-to-day HR management. They wanted to offer a powerful yet easy to use report writer that non- technical HR professionals can use across multiple HCM applications that provided design flexibility and powerful graphical presentation of data all automatically.
Various forms of robotic milking are helping sustain small to medium sized dairy farms amid broader industry consolidation and improving labor efficiency for some larger operations according to a new report from CoBank’s Knowledge Exchange Division
The U.S. Environmental Protection Agency (EPA) is inviting 39 projects in 16 states and D.C. to apply for Water Infrastructure Finance and Innovation Act (WIFIA) loans.
The Water Research Foundation (WRF) is seeking pre-proposals for the Subscriber Priority Program. The Subscriber Priority Program is designed to encourage collaboration with WRF Subscribers on research projects.
Smurfit Kappa Group plc ('SKG' or the 'Group'), one of the world's largest manufacturers of paper-based packaging products, with operations in Europe and the Americas, is pleased to announce that it has agreed to acquire Fabrika Hartije d.o.o. Beograd (‘FHB’) paper mill and Avala Ada d.o.o. Beograd (‘Avala Ada’) corrugated plant, in Belgrade, for a consideration of €133M (the ‘Transaction’) from Kappa Star Group
Recently, the U.S. Environmental Protection Agency (EPA) announced it has approved and helped fund a $327.7 million plan by Maryland to implement key water infrastructure projects, including new and upgraded wastewater treatment plants to better serve residents, increase efficiency and reduce pollution to local waters and the Chesapeake Bay