SOPs/WPDs Written for Clinical and Post Marketing
Audits and Inspections Performed Globally
Specialists in global clinical and post marketing drug safety
PharSafer® understand the importance of being compliant and not only passing or ‘getting through’ audits and inspections but excelling in them; applying a constant quality improvement philosophy through the work of our White Gloves Audit Group, with over 75 years of senior auditor experience performing GCP and GPV audits against multinational legislation requirements, as well as 21 CFR Part 11/GAMP 5 audits on system validations.
When forming a partnership with a client, we agree to see ourselves as an extension of their brand and Company ethos, protecting their reputation as we would our own, as we understand that any failures in compliance may result in significant consequences to their brand and to their product’s ability to produce revenue; guaranteeing that all standards of work are upheld to the highest possible standard, both within PharSafer® and in any external audits conducted.
Key Audit Services Offered:
- Helping Companies establish and strengthen their Quality Management Systems (QMS);
- Helping define Regulatory standards and establish Key Performance Indicators (KPIs);
- Ensuring standards are maintained for regulatory submissions via consistent measurement;
- Writing/review and strengthening SOPs & other Detailed Written Procedures;
- Performing Pre-Qualification (including risk assessments) and Partner Audits;
- Performing Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) audits, in line with multilingual legislation, as well as system validations;
- Providing gap analysis for process improvements;
- Audit for Due Diligence activities for Company or product purchases
