Dear Sir,
Thank you for your valuable comments.
Can you please suggest, is there any other activities to be performed apart from Establishment Registration for United States for this change. Like Self-Identification, Drug Listing, any amendment submission for the approved ANDAs etc.
Waiting to hear from you.
Thank you again for your time and suggestion.
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SUJAN BOSE
Tangail
Bangladesh
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Original Message:
Sent: 06-Jun-2023 03:12
From: Richard Vincins
Subject: Company name change from Limited to PLC
Anon,
In the United States it is quite easy, log-in to the FURLS system and update the Establishment Registration information; this can be done at any time. In the European Union the information can be updated n the EUDAMED, if registered there, or notification to your Notified Body on the name change (should not initiate anything more). Other regulatory agencies may have similar type of approaches - usually a small change like this in the name would not trigger anything more.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 05-Jun-2023 13:37
From: Anonymous Member
Subject: Company name change from Limited to PLC
This message was posted by a user wishing to remain anonymous
Dear experts,
Would you please enlighten me about the regulatory changes required when a company changes from a limited company to Public limited company? Definitely, in the name of the company (or I must say applicant and establishment name) would reflect this change. For Example, ABC Limited is changing to ABC PLC. What are the submission required for USFDA, like ER, Self-ID, listing or any other?
Could you please briefly advice?
Please help me out, I am new here.
Thanks for your time.