Reghelps SRC Empowers India's Booming IVD Sector with Specialized Support

Reghelps SRC offers targeted services to support Indian IVD manufacturers facing challenges in complying with European In Vitro Diagnostic Regulation (IVDR). Their offerings focus on performance evaluation, regulatory strategy, site management, and post-market planning to help manufacturers demonstrate robust evidence and access global markets.

In a move to bolster India's growing in vitro diagnostics (IVD) sector, Reghelps SRC has announced a suite of services tailored for Indian manufacturers navigating the complexities of the European In Vitro Diagnostic Regulation (IVDR 2017/746).

The IVD industry in India is rapidly expanding, yet manufacturers face hurdles in data collection and regulatory compliance. Issues such as data and evidence gaps, study design challenges, and regulatory demands are common. Reghelps SRC aims to address these by offering comprehensive support in performance evaluation and regulatory strategy.

Reghelps SRC's specialized services include designing analytical protocols, managing clinical sites, and preparing robust regulatory dossiers to facilitate quicker approvals. Founders Soio George and Nagachandra emphasize the importance of strong performance evidence in accelerating market access for innovative Indian diagnostics.

(With inputs from agencies.)