Regulatory Intelligence in Pharmacovigilance

"As part of our ongoing regulatory intelligence activities,
QVigilance team actively monitors websites, newsletters,
and RSS feeds of regulatory authorities and international
standards organisations; as well as reviewing
relevant articles and blogs"

Esther Poole
PHARMACOVIGILANCE SPECIALIST

Ongoing Monitoring Services

QVigilance continuously monitors regulatory information from local, regional and global authorities and organisations for pharmacovigilance-related regulatory intelligence to ensure that we and our customers are always up to speed and thereby maintain compliance with the latest regulatory requirements and guidelines for both investigational and authorised products.

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A Guide to the US FDA Safety ...

31 Jul, 2019

To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a medicinal product, it is the responsibility of the applicant to have in place a robust Pharmacovigilance ...

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QPPV and PSMF requirements update ...

19 Mar, 2019

On 12 Mar 2019, Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK ...

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MHRA e-Submission Update in ...

06 Mar, 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to make regulatory submissions for all regulatory and periodic vigilance submissions. This will include clinical trial ...

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