i3 infotek, an MSRcosmos Group firm founded in 2003, provides professional consulting services to Life sciences, Medical Devices, Biotechnology, and Healthcare organizations. We specialize in computer system validation, engineering, regulatory compliance, and digital transformation. Our highly experienced staff can assist you in identifying the appropriate personnel and skill sets to meet a broad range of R&D, scientific, engineering, packaging, quality, and regulatory requirements.

A wide-ranging and profound relevance

The engineering, architectural design, and consulting services provided by i3 infotek are compliant with the ISO 13485:2016 standard. We aim to give you a competitive edge by assisting you in designing, building, and operating manufacturing facilities that comply with international Good Manufacturing Practice (GMP) regulations issued by regulatory agencies such as the US FDA, EU EMA, CFDA, and PIC/S member agencies such as the Australian TGA, New Zealand MedSafe, and Singaporean HSA, to name a few of the nearly 50 agencies.

How do we make a difference?

The quality engineers at i3 infotek are vital to the enterprises in establishing best of breed practices governed for Life sciences, Medical Devices, Biotechnology, and Healthcare industry. Experience and deep expertise are crucial to gaining regulatory approval and achieving early success. Our customer-centric approach guarantees you receive just the assistance you require.