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We are a company formed by healthcare professionals with extensive experience in all types of health surveillance activities, as well as in the integration of quality systems in this area.

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EMA has issue clarifications on what consitutes “significant non-compliance” when it comes to notifying EMA and relevant NCAs these situations including what types of ICSR notification delays are considered significant

May 8, 2025

T1, T2, T3

A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 148)

May 8, 2025

T2, T3

A new version (1.9) of the chapter 7 (‘Submission of other post-authorisation data’ of the document ‘EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database’

May 8, 2025

T1, T2, T3

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Medicines for human use

Medicines for veterinary use

Clinical trials

Medical devices

Cosmetics

Audits

News

EMA has issue clarifications on what consitutes “significant non-compliance” when it comes to notifying EMA and relevant NCAs these situations including what types of ICSR notification delays are considered significant

A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 148)

A new version (1.9) of the chapter 7 (‘Submission of other post-authorisation data’ of the document ‘EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database’

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Zaragoza

Pamplona