I3CGLOBAL expands WHO Prequalification (WHO PQ) consulting services for Global IVD manufacturers

I3CGlobal

The new service streamlines technical documentation and QMS under one roof

BANGALORE, INDIA, March 14, 2025 /EINPresswire.com/ -- I3CGLOBAL, a leading medical device and Invitro diagnostic regulatory consulting firm has enhanced its WHO Prequalification¹ (WHO PQ) consulting services, helping Global manufacturers meet WHO standards for global market access.

The WHO Prequalification program is crucial for companies seeking approval to supply in vitro diagnostics (IVDs), to international organizations such as UNICEF and the Global Fund. I3CGLOBAL’s expert-driven approach ensures that manufacturers meet WHO's stringent regulatory, quality, and safety requirements efficiently.

Achieving WHO Prequalification can be complex, but with our deep expertise in regulatory compliance, we guide manufacturers through the entire process, from QMS implementation, and dossier preparation to regulatory submissions and audits," said Soio George, expert at I3CGLOBAL.

I3CGLOBAL’s WHO PQ consulting services cover:
✅ Pre-submission guidance – Reviewing eligibility and preparing regulatory strategies.
✅ Dossier compilation & submission – Ensuring compliance with WHO guidelines.
✅ GMP, ISO 13485 support – Helping clients meet global QMS standards.
✅ Regulatory liaison – Facilitating smooth communication with WHO and relevant bodies.

With over two decades of regulatory experience, I3CGLOBAL continues to support global healthcare innovation by enabling manufacturers to access international markets with WHO-compliant products.

For a detailed proposal on I3CGLOBAL’s WHO Prequalification consulting services, submit an online request² or contact enquiry@i3cglobal.com.

About I3CGLOBAL
I3CGLOBAL is a trusted regulatory consulting firm specializing in medical device, pharmaceutical, and in vitro diagnostic (IVD) compliance. With a proven track record of successful FDA, CE, and WHO approvals, the company supports global manufacturers in meeting stringent regulatory standards.

SOIO AUGUSTINE GEORGE
I3CGLOBAL REGHELPS PVT LTD
email us here

¹ https://www.i3cglobal.com/who-prequalification-who-pq/
² https://www.i3cglobal.com/who-pq-quote-request/