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    Power Up: Best Practices for Regulatory Intelligence

    Information is power. But in this era of information overload, if it were the sole requirement to be powerful, we’d all be Hercules. For regulatory professionals, the tool necessary to turn information into power is regulatory intelligence (RI). 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 essentia...
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    5 Myths About Regulatory Intelligence

    Even as regulatory intelligence (RI) 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 RI into your daily work to develop the most effective regulatory strategies and avoid costly, time-consuming missteps—in short, to be the best regulatory professional you can be. Myth 1: It Takes a Lot of Expertise ...
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    Keeping an Eye on Corporate Integrity Agreements

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Even in the world of healthcare product regulation, the initials CIA sti...
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    Not all Who Wander are Lost: The Search for Regulatory Intelligence

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com . "Not All Those Who Wander Are Lost" -- J.R.R. Tolkien As regulatory affairs...
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    The Tip of the Iceberg: What Lurks Beneath the 483

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com . At the end of a grueling week spent sitting in a conference room with an in...
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    Does FDA Take Longer to Clear 510(k)s From Non-US Companies?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com With respect to FDA 510(k) premarket clearances, the country where the submitter i...
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    Guess Which International Medical Device Facilities are Most Likely to be Inspected?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Let’s say you have responsibility for international facilities in Germany, China a...
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    When FDA Comes Calling, Do US Companies Fare Better Than Others?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Last month we explored the rates of US Food and Drug Administration (FDA) inspec...
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    When the FDA Inspector Comes, What are the Chances of a Really Bad Outcome?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com It’s generally nerve-wracking when the US Food and Drug Administration (FDA) sho...
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    What's the Best Time to Submit a 510(k) Application to FDA?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com .  What if there was a particular month when your submission would be cleared f...