Most of us are trying to simplify our schedules and remove meetings from our calendars. However, there is one scenario where the potential for more meetings is actually a good thing. That is when you are preparing to submit a regulatory application to a health authority, such as an Investigational [click to read the full story]
The effects of the U.S. government shut down and the impact on how FDA is working is all anyone seems to be talking about. Chicken Little is clucking that there is no end in sight! For the small company, delays can be disastrous. However, product development can and chicken littleshould [click to read the full story]
By Ken VanLuvanee Recently in our conversations with sponsors, we’ve seen a significant uptick in clients using electronic means beyond just storage on hard drives to manage their documents. That’s a wonderful thing to see and we’re thrilled. In this age of purely electronic assets and required electronic only communication [click to read the full story]
by Lisa Jenkins VanLuvanee I believe that people are special. They are a unique combination of both intrinsic factors and external experiences. Even identical twins who share the same genetic compliment are different from one another in personality, desires, goals, objectives, and lifestyles. Like a snowflake, no two people on [click to read the full story]
By Ken VanLuvanee There appear to be two diverging strategies emerging in the life sciences industry these days – mega-consolidation (mergers and acquisitions) aimed at “efficiencies of scale,” and leaner, more focused organizations that make use of the best resources at the right times, regardless of where those resources exist [click to read the full story]
by Bruce Salkovitz Introduction This is the third in a series of blogs that look at the essential requirements for document management solutions for small teams: SIMPLE, SECURE and COMPLIANT. You can check out our previous blogs in the series. This blog will focus on COMPLIANCE. Whether your team’s goal [click to read the full story]
by: Bruce Salkovitz Introduction This blog is second in a series that describes the essential requirements of a document management solution for small life sciences teams. Facet Life Sciences defines the three critical attributes as: Simple, Secure and Compliant. This blog will focus on the requirement for security. We look [click to read the full story]
by: Bruce Salkovitz Simple, Secure, Compliant. Small life sciences teams produce and manage a great deal of R&D documentation. Their development partners and other external resources add to this content throughout the R&D lifecycle. This documentation represents years of time, effort and money and it is incredibly valuable. It should [click to read the full story]
Reproduced with permission from DIA North America. You can see the original here. By Sarah DeMare, Facet Life Sciences Quality by Design (QbD) was introduced nearly ten years ago as part of FDA’s 21st century quality initiative. The ultimate goal is to reach the desired state of quality defined by [click to read the full story]
Suburban Philadelphia, PA – USA – September 1, 2015 – Facet Life Sciences Inc. (formerly VRS), the leading provider of expert regulatory solutions designed for small teams, today announced that the Company will be exhibiting at AusBiotech 2015 on October 7-9, 2015. The conference is Australia’s premier biotechnology conference and will [click to read the full story]