Regulatory Open Forum

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  • 1.  Mergers & Acquisitions: Regulatory Reference?

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    Can anyone recommend a good reference (book, website, training, etc.) that can guide a regulatory team through the proper steps and considerations when acquiring a company?  Our Regulatory team is new to this and while we have a good idea as to what we need to do, it would be nice to have a more formal guide that we can follow and communicate to our partners and stakeholders.  Thank you in advance!


  • 2.  RE: Mergers & Acquisitions: Regulatory Reference?

    Posted 11 days ago
    Hello Anon,

    There are quite a few resources out there (there is even a Mergers & Acquisitions for Dummies book), but I think you would be hard pressed to find anything specific to regulatory affairs or even quality assurance.  I have seen some white papers by groups like Deloitte or law firms - even see examples of Due Diligence checklists or audit criteria when examining a company to purchase.  However, in my experience the due diligence I have performed or been involved with we had developed our own criteria for what we reviewed, i.e. current regulatory status of products, regulatory issues such as open Warning Letters or adverse event content, or basic quality system compliance such as to an ISO 13485 standard.  I know when we developed these due diligence tools it was a combination of the normal Acquisition information out there (I gleaned information myself from some of those white papers) and our own experience on what we would want to see.  Interesting topic indeed though as I am not aware of a specific resource for medical device/pharma and quality/regulatory which could be used.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Mergers & Acquisitions: Regulatory Reference?

    Posted 11 days ago
    Hi Anon.

    Having been involved in a few M&A activities in my career, I would agree with Richard.  Unfortunately there is no "reference manual" for what to look for when it comes to Regulatory requirements in the M&A world.  We developed a lot of our own tools because one thing we found very early on and it has been proven true repeatedly in my own experience - every company has their own problems/issues/skeletons that you as the acquirer will need to understand and account for in your risk management and if the deal goes forward in your own remediation plan for whatever the issues are.

    We always started with some basic information around some of the areas that Richard mentioned plus we would use things like web searches, social media connectivity, international scope, and even organizational charts to determine what sort of information we would ask for.  We also tried to keep the number of sequential requests to a minimum (usually no more than 2-3 depending on the size of the acquisition target) by doing significant research up-front with a very limited number of our team members who would get involved literally almost as soon as the company was identified as a target for acquisition.  That small group would pull together everything they could find (and they found plenty) in just basic internet searches and looking through compliance agency websites.  That was all accounted for as well when we initiated our first questions for the early due diligence work and it also allowed Regulatory a seat at the table in the pre-overture discussions of whether this particular company was one that we would want to actually target for acquisition.

    And hey - look at the bright side of there being no references specifically out there:

    1. You can't be told "You did it wrong" because there is no "right" answer to this question.
    2. There is a vacuum that you might be able to fill (if you were so inclined) with a more specific resource in the future.
    3. Maybe there is a RAPS reference article (more likely a book!) to be had in this area specifically written by people in the field for people in the field!

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    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
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  • 4.  RE: Mergers & Acquisitions: Regulatory Reference?

    Posted 11 days ago
    I'd be interested in some insight to this as well as we recently through this and I have not experienced M&As in my past. There is an FDA guidance document for transferring ownership in FURLS. We acquired a company and their devices but that company does not continue to perform any operations under it's registration but I need to pay/renew their registration listing based on this document. How can we retain the link of the 510k ownership and transfer to the new organization if the original organization no longer physically exists?
    https://www.access.fda.gov/drlm/help/TransferOwnershipOfDevicesAndFacilities.html

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    Stacey Benser
    Senior Quality/Regulatory Manager
    York PA
    United States
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  • 5.  RE: Mergers & Acquisitions: Regulatory Reference?

    Posted 6 days ago
    Stacey,

    You can retain the 510(k) ownership and medical device listing for an organisation, but you would need the log-in information from the FURLS system (this is assuming you are talking about US FDA).  This goes back to creating a list for what information would be needed not only during a Due Diligence audit, but then through the actual merger/acquisition.  I have seen time and time again where it is a headache trying to re-establish product registrations because the log-ins for regulatory agency registrations "went with someone" or sitting in a person's password list who was not part of the transfer.  Nobody deemed to ask about the log-in and passwords, and when you are cut out of your job, not so willing to be helpful.  If you do not have the log-in information, it becomes even more challenging getting this reset especially if not in your origin country.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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