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  • Hi Fellows, Background -There is this product that is packaged in a blister and sterilized in EtO. -The current version is an adoption of the previous version. -The previous version was validated, and it included multiple cycles of sterilizations. -Both versions are made of the same material. Situation A functional problem was identified ...

  • Posted in: Europage

    My question is focused on who should be conducted all of the necessary planning, research, review, and authoring activities for a CER.  The way I interpret MEDDEV 2.7/1 revision 4 is that  the person qualified as the "evaluator" for a CER has responsibility for carrying out ALL of the activities required for a CER, including defining the evaluation ...

  • You can replace your CFDA legal agent during the registration phase.  If you are on the final stages of submission, I assume that you have received the 1st supplement notice and ready to address the supplement questions.  This is a very critical phase.  You have one year to prepare and file.  We have dealt with this type of situations before for clients ...

Martha Brumfield Discusses Her Regulatory Career Path

"In addition to professional enrichment, the job of a regulatory professional is personally fulfilling. While our work may be separated from the clinics and doctors' offices where the products we support are used, in the back of every regulatory professional's mind is the knowledge that the work helps people live healthier lives. Every step of the way, we are fighting for patients."" 

Martha Brumfield, PhD 


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