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Services: Pharmacovigilance


Pharmacovigilance (PV) as defined by the World Health Organization (WHO) is the "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem".  Of course, an adverse incident can also occur in relation to all products used in healthcare including medical devices and diagnostics.


An adverse effect or adverse drug reaction (ADR) is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as "an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs, and is suspected to be related to the drug. The reaction may be a known side effect of the drug or it may be new and previously unrecognised".


An adverse incident involving an healthcare product is defined by the MHRA as “an event that caused, or almost caused, an injury to a patient or other person or a wrong or delayed diagnosis and treatment of a patient”


Via a strategic partner, GRS can provide companies with a complete Pharmacovigilance Package which includes the following:



Please contact us with your specific regulatory compliance requirements.




GRS is a community of reputable independent professionals and specialists throughout the world