Monnox Pharmaceutical Consultants are dedicated to Regulatory and Statutory compliance in the fields of Pharmacovigilance, Quality and GMP.
See our website for details on the service offering: www.monnox.co.za
The international regulatory environment is constantly
evolving and the South African guidelines are being
updated regularly, so as to bring us into line with EU, US
and WHO recommendations.
With an increased global interest in drug safety and demand
for more transparency in the pharmaceutical sector, can
you afford to be non-compliant in the field of VIGILANCE?
Monnox Pharmaceutical & Vigilance Specialists’ expertise
in regulatory and statutory requirements, coupled with our
reputation for technical knowledge accrued, enables us to
provide a range of consulting services in the pharmaceutical
industry.
Vigilance Services*
• Design and Implementation of VIGILANCE systems
• Case reporting of ADRs
• VIGILANCE training
• 24-Hour In-coming call handling
• Assistance with Literature Searches
• Drafting of VIGILANCE Agreements
• Medical Assessments of ADRs
General Pharmaceutical services
• Customised Standard Operating Procedures (SOPs)
• Risk Management Support
• Marketing Code Compliance
• Drafting of QUALITY and TECHNICAL agreements
• Training of pharmaceutical support staff
• Handling of complaints
• Sterile compounding expertise
