The MDSAP audit fulfills the requirements of the following regulatory authorities:

a woman with curly brown hair and black-framed glasses sits at a desk in a bright office environment. Wearing a blue-and-white pinstriped button-down shirt, she reviews printed paper documents held in both hands while looking intently toward an open silver laptop placed on the desk in front of her. A smartphone sits nearby on the desk surface.
  • Therapeutic Goods Administration of Australia (TGA)
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • Health Canada (HC)
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW & PMDA)
  • U.S. Food and Drug Administration (FDA)

Benefits of MDSAP + CE combined audits

a close-up side view shows a person sitting at a wooden desk in a modern office or café setting. Wearing a white long-sleeved shirt, the person rests one hand on a black clipboard filled with business documents containing pie charts and bar graphs, holding a pen. Their other hand gestures toward the screen of an open laptop sitting on the table alongside additional scattered financial reports.
  • Shorter total processing time
  • Cost reduction
  • Reduced lead time
  • A global partner with local experts close to you