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RE: Derivation of product requirements from regulatory information/standards - Best practice?

Posted by: Anne LeBlanc, 20 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Best practice includes early communication and negotiation about requirements at a high level. First the Marketing function may say where are the target markets and the Design function may suggest the read more
RE: Qualification of alternate site for drug substance micronization

Posted by: Tom Stothoff, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Thank you, Robert. Peter - as I stated, we are currently in Phase 3 so NDA has not been submitted yet. Plan is to list both sites in NDA since we will have manufactured PV lots before NDA submission read more
RE: RA Consultant for Software in/as Medical Device

Posted by: Sean Mitchell, 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Anon, StarFish Medical's Regulatory team can help you with this task. We have an internal Software Engineering team that has experience with this sort of thing, so we understand it from a regulatory read more
RE: RA Consultant for Software in/as Medical Device

Posted by: Kevin McLellan, 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi Anon. I can help with you with this. I provide regulatory expertise for device manufacturers, including many software developers. Pls visit my site for more. medtechresults dot com. Or reach me read more
RE: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

Posted by: Christoph Kiesselbach, 3 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi Anon, would the main mode of action of the overall package depend on the MP or the MD? So for example, is this a combination where an MP is accompanied by MDs that allow its administration (mode of read more

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Unanswered posts

ICH Q2(R2)/M14 expectations

By: Anonymous Member , 5 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Dear all, Q2(R2) states that "Accuracy should be reported as the mean percent recovery of a known added amount of analyte in the sample or as the difference between the mean and the ...
China registration testing samples

By: Anonymous Member , 5 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Per China "Specification for Procedures and Technical Requirements of Drug Registration Testing (Trial Version)": The samples for registration testing should be manufactured on a commercial ...
Fostering a Culture of Quality

By: Anonymous Member , 5 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hoping for some input from this community re: initiatives that have been effective at fostering a culture of quality within your organizations. Thank you!
21 CFR reference on compendial method replacements

By: Anonymous Member , 5 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous I remember reading a 21 CFR regulation stating that if a sponsor plans to use a non-compendial method when a compendial method is available, a head-to-head comparison should be included ...
Stability and Shelf-life using accelerated - FDA ICH ...

By: Anonymous Member , 5 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello Forum! We are currently having discussion regarding initiation of stability studies and the whether the application of a shelf-life to general medical devices (wound care products, ...