Retail buyers and merchandisers are continuously tasked with sourcing new merchandise and comparing to existing products to ensure their product lines remain competitive in the marketplace. With multiple seasons and programs to support, it is challenging to identify new supply sources, review new products with existing suppliers, negotiate contracts and confirm timely supplier production runs.
Natoli Engineering’s NP-P20A single-station hydraulic tablet press is a favorite for the production of injectable micropellets and for marginal formulations requiring deep-fill. The NP-P20A meets the FDA’s requirements for batch reporting and secure data management under CFR 21 Part 11 compliance.
Pre-packed with your choice of Praesto modern, high-flow agarose resin for cost-effective, high productivity MAb purification.
The automatic self-cleaning filter - suitable for more applications than ever.
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.
While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.
The growth of single-use in cGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology is meeting these challenges at every process step and application of biomanufacture.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
Over the past decade, advances in oncology research have resulted in many new treatment options that include immunotherapies. This article examines these newer therapies in more detail.
Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.
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.
Today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills
Medidata RCM provided Zosano Pharma with a unified solution for standard operating procedure (SOP) management, for both regulated and non-regulated content eliminating their old system of using a file server system with folders containing PDF documents that needed to be tracked and traced manually.
How and why leading institutions have made the decision to switch from reliance on just one external IRB to partnering with multiple independent IRBs.
The pre-mobile enabled field service organization, which is quite common despite available technologies and almost ubiquitous connectivity, is one that still relies heavily on manual processes and paper-based forms for field service delivery. At best, this traditional organization may use multiple spreadsheets for data entry and job tracking. Due to the lack of a mobile process, field service directors and managers have no insight into the locations of their field techs, the status of jobs in progress, or real-time data on which to escalate or downgrade problems.
Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.
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.
The Water Research Foundation (WRF) is currently funding research through a grant from the State Water Resource Control Board in California to understand water quality after advanced water treatment and how these contaminants can be mitigated.
Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms, today announced that it has completed the acquisition of Avista Pharma Solutions (“Avista”), a contract development, manufacturing, and testing organization, from Ampersand Capital Partners.
Recently, to assist communities recovering from the devastating impact of Hurricane Michael, and at the direction of Governor Rick Scott, the Florida Department of Environmental Protection (DEP) is offering the suspension of up to $12M in wastewater and drinking water facility loan repayments and interest accrual for two years.
The U.S. Environmental Protection Agency (EPA) received 62 letters of interest (LOIs) collectively requesting $9.1B in loans from a wide range of prospective borrowers in response to the Water Infrastructure Finance and Innovation Act (WIFIA) program’s 2018 Notice of Funding Availability.
More than 50 percent of dairies have more than 1,000 cows, up from 29 percent just 10 years ago, showing consolidation of dairy operations has increased significantly