At Red Line we ensure that your business has the best Pharmacovigilance support in the industry
 
 

 External Audits

Competent Authorities regularly exchange information about the non-compliance and regulatory actions taken against Marketing Authorisation Holders.

Marketing Authorisation Holder's are expected to monitor their pharmacovigilance systems and processes for compliance with regulatory guidelines.  These activities should be carried out separate to or in preparation for a regulatory inspection.

External CAPA (Corrective & Preventative Actions) Audits can be requested to review your company's or your current provider of Medical Information handling and Pharmacovigilance functions.

At Red Line we can assist you in this process and help to ensure a robust system of Pharmacovigilance is in place by thorough analysis of your detailed description of pharmacovigilance, safety reports and standard operating procedures.

 

 Review and restructure your existing pharmacovigilance process.


Medical Information

Pharmacovigilance

Literature Monitoring

Copy
Approval

Training

Professional enquiry handling to support the safe and effective use of your products. Ease the regulatory burden and keep compliant with current pharmacovigilance legislation. Product safety through surveillance of published articles and case reports. A comprehensive technical review and final signatories for all promotional materials. Confident staff to support the pharmacovigilance process.

 
 
METS Contact us on (01908) 363 436 Copyright © 2017 Red Line Ltd (Registered in England & Wales : 07395811)
 
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