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Industry:Pharmaceuticals

Site:uk.linkedin.com

Description:Pharmacovigilance consultancy providing adhoc resource to pharmacovigilance groups and expertise to companies and organisations lacking pharmacovigilance experience.
Specialises in pharmacovigilance writing and training:
• Regulatory submissions – MAA, NDA.
• Risk management plans – EU RMPs, Global RMPs, REMs.
• Periodic reports (PBERS/PSURs, DSURs).
• Signal detection and evaluation, regulatory responses, labeling, case narratives.
• Pharmacovigilance training.

Founded:2010

Company size:Myself Only


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