Our work
Here's a summary of our experience in our core services in PV QA activities.
We are open to other projects in related areas such as Quality Management and Pharmacovigilance.
Audited in 7 regions and over 40 countries
Asia Pacific: China, India, Japan, Philippines, South Korea, Taiwan, Thailand, Vietnam
Australaisa: Australia, New Zealand
Central Asia: Kazakhstan
Europe: Austria, Bulgaria, Cyprus, Czech Republic, Estonia, France, Germany, Latvia, Lithuania, Netherlands, Portugal, Romania, Slovakia, Sweden, Switzerland, Ukraine, United Kingdom
Middle East: Israel, United Arab Emirates, Saudi Arabia
Latin America: Argentina, Brazil, Columbia, Mexico
United States
Audits conducted in
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System/Process
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Affiliates
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Service Providers
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Licensing Partners
Inspection support
Fully supported on-site, remote, and hybrid (part onsite and remote) inspections for:
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Europe's EMA - GVP and GCP
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UK's MHRA - GVP and GCP
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Sweden's MPA - GVP
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Health Canada - GVP
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Germany's BfArM - GVP
Provided support to other Health Authorities' inspections such as Slovakia's SUKL, Itay's AIFA, China's NMPA, and the U.S FDA.
Training
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Basic PV Training
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Audit Training
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Inspection readiness training
Please get in touch to discuss your individual needs...
Please get in touch!