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

Posted by Mandy Gervasio on Nov 13, 2017 2:33:50 PM

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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Attend "Core Components for Contamination Prevention & Control in Biopharma Manufacturing Operations"

Posted by Stephen Fochios on Mar 7, 2017 9:50:00 AM

On April 4th, 2017, EG Life Sciences will host a breakfast event at MassBio that will feature Gary C. du Moulin, Ph.D., M.P.H., RAC who will present "Core Components for Contamination Prevention and Control in Biopharmaceutical Manufacturing Operations." Gary recently retired as Senior Director of Quality Aseptic Control for Genzyme (a Sanofi company) where he participated in the development and execution of robust quality systems for Genzyme's products including biologics and cell based therapies.

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A Look Back at FDA Approvals in 2016: The Downturn

Posted by Alan Greathouse on Jan 24, 2017 9:45:00 AM

We all know 2016 was one for the ages and in the world of FDA Approvals the same can be said.

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Who's leading in biotech in 2017? East Coast vs. West Coast

Posted by Stephen Fochios on Jan 10, 2017 11:40:00 AM

California and Massachusetts are always mentioned together when speaking about the leading life sciences clusters in the US. They frequently share the number one and number two spots on the many lists that are published in the scientific community. The reason? The abundance of world class educational institutions in these areas give companies easy access to top level talent.

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The Process Validation Life Cycle

Posted by Alan Greathouse on Dec 14, 2016 11:05:00 AM

As times change so do the expectations of the regulators. This holds true with validation as well. More global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. Let’s take a quick look at how the definition of Process Validation has evolved:

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How to Handle Out of Specification (OOS) Results

Posted by Stephen Fochios on Nov 15, 2016 10:51:07 AM

Your cold room just went down: now what?

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Preparing for Successful Pre-Approval Inspections (PAI)

Posted by Stephen Fochios on Sep 19, 2016 1:10:00 PM

What is a Pre-Approval Inspection? For pharmaceutical companies, this FDA inspection is intended to determine whether their facilities, manufacturing processes and controls used to produce and package drug products are adequate to ensure the safety and quality of their products. The FDA wants assurance that problems that arise during the drug manufacturing process are investigated properly and that quality systems are in place to document and remediate these issues in a timely manner.

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

Posted by Stephen Fochios on Jul 19, 2016 4:30:00 PM

In my recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team on hand that is 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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What consultants should look for in a life sciences consulting firm

Posted by Dana Tarlow on Jun 27, 2016 1:30:00 PM

Given the lightning pace of business at medical device, pharmaceutical, and biotechnology firms these days, it’s no wonder that more and more companies seek talented, experienced consultants who can quickly ramp up to work on critical projects. EG Life Sciences partners with life sciences companies to locate top talent to meet this demand and works closely with consultants to match them to these opportunities.

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Prepping for a Successful FDA Inspection: Site Inspection Readiness Team

Posted by Stephen Fochios on Jun 15, 2016 10:30:00 AM

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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