Shandon McGee Pharmacovigilance Company

"Ignorance is no defence when the Inspector calls and beware of false knowledge; it is even more dangerous than ignorance"

In today’s highly regulated pharmaceutical environment it is crucial that your company is compliant with all pharmacovigilance legislative requirements. The consequences of non compliance will be catastrophic for the continuity of your business.

Shandon McGee Pharmacovigilance Company (SMPC) have worked for the regulators and the pharmaceutical industry. Our industry experience and regulatory backgrounds uniquely position us to provide you with the services to meet and exceed your legislative compliance obligations.


 

Periodic Safety Update
Reports


Marketing Authorisation Holders
(MAH’s) are required, post authorisation of a medicinal product, to provide a Periodic Safety Update Report (PSUR) at defined times to Competent Authorities. 

 

 


 

Summary of Product
Characteristics


The Summary of Product
Characteristics (SmPC or SPC) is an essential part of the Marketing Authorisation. The SPC defines the core information about the medicinal product as distilled during the course of the regulatory assessment process.
 


 

Adverse Event Reporting
 


Clinical trials and drugs in the marketplace have the potential to produce adverse drug reactions (ADRs). Adverse event reporting requires the tracing of all complaint information and the generation of the appropriate reports for the relevant regulatory authorities.