Pre-Inspection Audits

We provide guidance and conduct GAP analysis audit before final inspection/audit by following authorities:

• US Food and Drug Administration (FDA)
• UK Medicines and Healthcare Products Regulatory Agency (MHRA)
• AUSTRALIA Therapeutic Goods Administration (TGA)
• CANADA Health Canada
• EUROPE European Medicines Agency (EMEA)
• GERMANY Federal Institute for Drugs and Medical Devices
• BRAZIL Agencia Nacional de Vigiloncia Sanitaria (ANVISA)
• JAPAN Ministry of Health, Labour & Welfare (MHLW)
• ROW Regulatory audit
• WHO GMP
• NSF
• ISO 9001
• ISO 13485