Search Results for RIQ

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Power Up: Best Practices for Regulatory Intelligence By Sharon DeGrove Bishop, RAC - Published 14 April 2016

Regulatory intelligence allows you to use information to be proactive rather than reactive. RI has grown from a “nice to have” option that was owned and operated exclusively by large companies into a key instrument essential to every regulatory affairs practitioner’s success.

Categories: HTML, Articles, Under RAPS, Regulatory intelligence

Tags: regulatory intelligence, Graematter, RIQ, Regulatory Intelligence Quotient

4 Reasons to Invest in Regulatory Intelligence By Diane Fleetwood - Published 01 February 2016

Justifying the need for regulatory intelligence investments is uniquely challenging—so where do you even begin to convince your organization that RI has value? Here’s what your organization may not know.

Categories: HTML, Articles, Under RAPS, Regulatory intelligence

Tags: regulatory intelligence, ROI, Graematter, RIQ, Regulatory Intelligence Quotient

5 Myths About Regulatory Intelligence By Sharon DeGrove Bishop, RAC - Published 16 October 2015

Even as regulatory intelligence emerges as a key tool for regulatory professionals, it’s still surrounded by myth and misinformation. In this article we’ll explore five common myths about RI and why you owe it to yourself to consciously incorporate it into your daily work to develop the most effective regulatory strategies and avoid costly, time-consuming missteps.

Categories: HTML, Articles, Under RAPS, Regulatory intelligence

Tags: regulatory intelligence, myths, Graematter, RIQ, Regulatory Intelligence Quotient

Keeping an Eye on Corporate Integrity Agreements By Sharon DeGrove Bishop, RAC - Published 23 June 2015

Even in the world of healthcare product regulation, the initials CIA still stand for surveillance and vigilance.

Categories: News, US, DOJ, FDA, Compliance, Ethics, Regulatory strategy

Tags: CIA, Corporate Integrity Agreement, RIQ, Graematter, Regulatory Intelligence Quotient

Not all Who Wander are Lost: The Search for Regulatory Intelligence By S. Albert Edwards, PharmD, RAC, FRAPS - Published 05 May 2015

As regulatory affairs practitioners, we may seem to be wandering. In reality, we're often searching: through that paper stack, those old records, CDs, DVDs, electronic listings, prior notes, or some established company or vendor-driven system to find that critical nugget of regulatory information.  

Categories: News, Regulatory intelligence

Tags: RIQ, Regulatory Intelligence Quotient

The Tip of the Iceberg: What Lurks Beneath the 483 By Marlene S. Bobka, FOI Services, Sharon DeGrove Bishop, RAC - Published 23 March 2015

At the end of a grueling week spent sitting in a conference room with an investigator from the US Food and Drug Administration (FDA), you may end up with an FDA Form 483 listing the inspectional observations that the agency has cited as potentially deficient.

Categories: News, US, FDA, Audit, Regulatory intelligence, Regulatory strategy

Tags: RIQ, Regulatory Intelligence Quotient, Graematter, FDA Form 483, Form 483, EIR, Establishment Information Report

Does FDA Take Longer to Clear 510(k)s From Non-US Companies? By Sharon DeGrove Bishop, RAC - Published 19 February 2015

With respect to FDA 510(k) premarket clearances, the country where the submitter is located doesn’t have any bearing on how long it takes to get clearance from the FDA. Or does it?

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: RIQ, Regulatory Intelligence Quotient, Graematter, 510(k), Special 510(k), Traditional 510(k), Clearance, Premarket Notification

Guess Which International Medical Device Facilities are Most Likely to be Inspected? By Sharon DeGrove Bishop, RAC - Published 08 January 2015

Let’s say you have responsibility for international facilities in Germany, China and Costa Rica, and each one is due for an inspection – you just don’t know which one would be the most likely to be inspected. With limited resources (as most of us have nowadays), how do you use regulatory intelligence to decide where to send your auditors first to ensure you’re prepared?

Categories: News, CDRH, Audit, Medical Devices, Regulatory intelligence

Tags: RIQ, Regulatory Intelligence Quotient, Graematter, FDA Facility Inspections, Facility Audit

When FDA Comes Calling, Do US Companies Fare Better Than Others? By Sharon DeGrove Bishop, RAC - Published 17 November 2014

Last month we explored the rates of FDA inspection conclusions for registered establishments within the US. Several readers posed questions about international inspections, so in this issue we’ll take a look at FDA inspections on a global scale.

Categories: News, FDA, Audit, Regulatory intelligence

Tags: OIA, VAI, NAI, Inspections, FDA Inspections, FDA Inspection Data, RIQ, Regulatory Intelligence Quotient

When the FDA Inspector Comes, What are the Chances of a Really Bad Outcome? By Sharon DeGrove Bishop, RAC - Published 21 October 2014

It’s generally nerve-wracking when the FDA shows up at your door for an inspection. Knowing what to expect can help.

Categories: News, US, FDA, Audit, Regulatory intelligence

Tags: OIA, VAI, NAI, Inspections, FDA Inspections, FDA Inspection Data, RIQ, Regulatory Intelligence Quotient

What's the Best Time to Submit a 510(k) Application to FDA? By Sharon DeGrove Bishop, RAC - Published 16 July 2014

What if there was a particular month when your submission would be cleared faster than any other month? Wouldn’t it be great to know that your submission is going into the US Food and Drug Administration (FDA) at the optimal time?

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: 510(k), 510(k) Filing, Best Time to Submit 510(k), 510(k) Filing Strategy, 510(k) Review Times, RIQ, Regulatory Intelligence Quotient