EU IVDR Requirements for Certification

Posted by EG Life Sciences

Is your company as far along as it needs to be?

The In Vitro Diagnostics Regulation, or the IVDR, was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (or IVDs). The IVDR will replace the legacy In Vitro Diagnostic Directive (IVDD) and should ensure a greater level of patient protection and provide rules and regulations that are more effectively implemented.

The manufacturers of these devices are well aware of the IVDR that will soon take effect. Most of these manufacturers are already taking the necessary steps to prepare to comply with this new regulation, but are they as far along in their preparations as they should be?

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Is Agile the Answer to Big Pharma's Digital Revolution?

Posted by Jennifer Mariani

In an age when your daily wants and needs can be delivered by Amazon, we are a culture of instant gratification. This culture has bled into all walks of life, including our medicine. In June of 2018, Amazon bought PillPack out of Cambridge, MA, for $753 million to crack into the $500 billion dollar prescription market. With this acquisition, customers can get meds delivered to their door with automatic refills and 24/7 customer support.

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How to Handle Out of Specification (OOS) Results

Posted by EG Life Sciences

Your cold room just went down. Now what?

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Net Promoter Scores: What Do the Numbers Really Mean?

Posted by EG Life Sciences
What are Net Promoter Scores?

Have you heard of Net Promoter Scores? A company’s NPS or Net Promoter Score is a measurement of customer satisfaction.1 These scores are especially useful in the staffing industry, in which feedback isn’t linked to a tangible product, but is instead related to a more subjective service or experience. For example, when a client says their experience with us was “good,” it’s difficult to derive true meaning from that response, especially as the definition of “good” likely varies vastly from client to client. Thus, the staffing industry was in need of a universally understood, tangible measure of a subjective experience. Enter NPS. While NPS surveys can ask a number of questions, the concept truly focuses on only one:

How likely are you to recommend your firm to a friend of colleague?2
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FDA Form 483 vs. Warning Letters: What's the Difference?

Posted by EG Life Sciences

When the FDA inspects a pharmaceutical or biotechnology company’s manufacturing facilities, they can either alert the company ahead of time or show up unannounced. After the inspection is over, the FDA might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.

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The FDA is On-Site! Checklist for FDA Site Inspections

Posted by EG Life Sciences

In our recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team always “at the ready” for FDA visits, regardless of whether the visits are scheduled or unannounced. But what happens once the inspectors arrive? You should have a checklist on hand for the key logistical considerations.

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The Risks of Insourcing All of Your Programming & Statistical Analysis

Posted by Antony Goncalves

Don't limit your team's ability to perform. Consider freeing up your best internal resources by using an outsourced team as an extension of your functional group. 

It’s certainly a challenge that most – if not all – companies face these days: which aspects of our business do we keep in-house, and which pieces do we outsource? And nowhere is that more of a challenge than within the regulated environment of the pharmaceutical industry.

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Prepping for a Successful FDA Inspection: Site Inspection Readiness Team

Posted by EG Life Sciences

For pharmaceutical, medical device, and biotech companies, being always “at the ready” for FDA inspections is an absolute necessity. While some inspections are predetermined, others are surprise visits, so it’s critical to have a team and a process in place to ensure you can respond to every inquiry effectively.

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Preparing to Comply with the EU MDR

WHAT IS IT?

The European Union put a new MDR, or Medical Devices Regulation, into effect on May 25, 2017. The MDR replaces both the former Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation has a transition period of three years, during which time manufacturers are expected to revise their internal production processes and related technical documentation to align with the new requirements put into effect by the MDR.1,2 Ideally, the replacement of the MDD with the MDR will encourage a greater universal compliance to stricter standards throughout Europe of regulations related to medical devices.

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Focus on Compliance: Scale Your Drug Manufacturing Capacity to Support the Product Lifecycle

Posted by Mandy Gervasio

Biopharma advancement is at an all-time high with breakthrough drugs and life-sustaining therapeutic treatments being developed, manufactured, and approved every day. It’s a space of incredible growth but also one that’s heavily regulated by the FDA and other global regulatory agencies.  Lately, there have been so many new products showing great promise and thus scaled up from Clinical Phase 1 through Late Phase Clinical II/III up to commercial launch. Clearly, there is a vast amount of work and resources required to support this growth curve. This post introduces key topics that impact the overall product lifecycle; during the coming weeks, we will subsequently break them down into tangible, action-oriented recommendations for success!

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