Preparing for Successful Pre-Approval Inspections (PAI)

Posted by Stephen Fochios

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 Risks of In-Sourcing All of Your Programming & Statistical Analysis

Posted by Antony Goncalves

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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An Introduction to the Standard Data Tabulation Model (SDTM)

Posted by Anilkumar Jangili

For programmers who analyze clinical trial data in the pharmaceutical and biotechnology industries, the Standard Data Tabulation Model (SDTM) is incredibly important and valuable. Prepared by the Submission Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC), the purpose of SDTM is to organize, structure and format standard clinical trial tabulation datasets submitted to regulatory authorities such as the US Food and Drug Administration (FDA).

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

Posted by Stephen Fochios

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

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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A Look Back at FDA Approvals in 2016: The Downturn

Posted by Alan Greathouse

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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Prepping for a Successful FDA Inspection: Site Inspection Readiness Team

Posted by Stephen Fochios

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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Become a Life Sciences Quality Assurance Consultant: What are the skills required?

Posted by Adam Holmes

In Deloitte’s 2016 Global Life Sciences Sector Outlook, the research points to “an ever-evolving regulatory and risk environment” coupled with the “growing prevalence of chronic diseases” as just two of the factors driving the growth of the biotech sector and the heightened need for skilled Life Sciences professionals.

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FDA Form 483 and Warning Letters: What's the difference?

Posted by Stephen Fochios

When the FDA comes in to inspect 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 can send what is called an FDA form 483 or a warning letter. There are differences and various consequences depending on how these are both handled.

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Life Sciences Clusters

Posted by Stephen Perez

According to Wiktionary – the wiki based, open content dictionary – a “cluster” is defined as “a group or bunch of several discrete items that are close to each other”.

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