Quality Assurance is an intrinsic part of MakroCare process and projects. MakroCare QAU is an independent department reporting to Executive Management. Our QA team has highly qualified and experienced auditors with sound knowledge on local, national and international regulations and guidelines. We have established Global SOPs and maintaining a Global Clinical Quality Management System in accordance with the requirements of all applicable standards and regulations (ISO:9001, ICH-GCP, US FDA, EMA, HSA and Schedule Y). QAU department brings strong experience to achieve customer satisfaction and deliver highest quality standard for all our services. Our facility is certified with ISO: 9001(QMS), ISO: 27001(ISMS) and ISO: 20000(ITSM).

QAU team works closely with both MakroCare and Sponsor’s teams in facilitating quality procedures and compliance. QAU applies MakroCare’s proprietary framework Clinical Total Quality Management (cTQM) to make the quality processes run in high standards which is far wider in its application than just assuring product or service quality.