Facet Life Sciences Blog

FDA Meetings: When More Meetings are a Good Thing!

Posted by Lisa Jenkins VanLuvanee on Feb 26, 2019 12:39:26 PM

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 New Drug Application (IND) to the U.S. Food and Drug Administration (FDA). Getting the FDA’s input into your application prior to submission is a critical step in the process. Because the meetings are typically scheduled for about an hour to an hour and a half, making good use of your time with the health authority is key.

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Topics: FDA Meeting, FDA

The Sky is Not Falling: Product Development Can and Should Progress During The Government Shut Down!

Posted by Lisa Jenkins VanLuvanee on Jan 15, 2019 12:44:35 PM

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 should continue! Now is a great time to think strategically to achieve your next development milestone(s).

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Topics: Document Management, Development Services

DMS, Document Sharing & eRoom Technologies: What’s Right For You?

Posted by Ken VanLuvanee on Oct 31, 2018 11:36:01 AM

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 with global health authorities, to see an increasing number of life sciences sponsor organizations recognizing the need to manage their electronic documents and treat them like to assets they truly are is a significant development within the life sciences industry.

We do, however, see a significant amount of confusion about what the various types of electronic systems available are and what they’re best suited to do, as well as what requirements (both practical and legal) each of those types of systems meet.

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Topics: Document Management

The Myth of Being Special

Posted by Lisa Jenkins VanLuvanee on Nov 1, 2017 9:55:48 AM

by Lisa Jenkins VanLuvanee

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Developing Therapies In a Lean Organization Using On Demand Expertise

Posted by Ken VanLuvanee on Aug 21, 2017 8:45:33 AM

By Ken VanLuvanee

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Document Management for Small Teams -Part 3: COMPLIANCE

Posted by Bruce Salkovitz on Jun 8, 2017 9:07:15 AM

by Bruce Salkovitz


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:

Blog on DMS Simplicity

Blog on DMS Security

This blog will focus on COMPLIANCE.

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Topics: Document Management

Document Management for Small Teams - Part 2: SECURE

Posted by Bruce Salkovitz on May 23, 2017 10:13:09 AM

by: Bruce Salkovitz


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 at security from two different perspectives – internet security and content security. Internet security addresses the connection from the user’s desktop to the document management system. Content security deals with permissions and access to specific files in the system.

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Document Management for Small Teams - Part 1: SIMPLE

Posted by Monique Garrett on May 12, 2017 9:54:56 AM

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 be managed and protected like any other important asset.

But traditionally, small teams have had to wrestle with document management solutions that were built for larger teams. These solutions typically require customization, long implementation projects and an existing IT infrastructure. 

What they really need is a solution that is… SIMPLE, SECURE and COMPLIANT.

This series of blogs will discuss what this means and how small companies can have the capabilities they require without the burden of a large, complex and expensive solution.

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