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Regulatory Affairs

Regulatory Affairs is as much a specialist area as Pharmacovigilance. From Regulatory Authority and Ethics/Institutional Review Boards submissions during the Clinical trial Phases to licence submissions and then post approval, it is a task best left to the experts.

Naturally, Pharmacovigilance and Medical Services work closely together with Regulatory and PharSafer® have over many years built up a network of every type of Regulatory specialist who will be able to work with us and help with all aspects of the Regulatory submission from pulling together the dossier for licence submission in line with either National requirements or the ICH M4 International standard (still with any National additions).

Additionally, the client can be guided through the assessment procedure and answering questions effectively during the submission process (the so-called ‘clock stop’) so that approval is not unduly delayed.

PharSafer® Tweets

The @FDA_Global has updated their summative COVID-19 response document, with amendments made for latest activities… t.co/j9oudR40O0

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@MedDRAMSSO have issued their official 'patient friendly' MedDRA list, fully compliant with the latest MedDRA versi… t.co/8dK50LBnWt

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The @FDA_Global has released a report regarding drug shortages for the calendar year 2019, with key considerations… t.co/L7HkKvfYqe

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