Reacta Healthcare, a leading developer and manufacturer of pharmaceutical-grade oral food challenge (OFC) products for food allergy diagnostics, has had its manufacturer’s licence and GMP certificate renewed and extended by the UK Government’s Medicines & Healthcare products Regulatory Agency (MHRA).
The company has held an MHRA manufacturer’s licence for the past five years. Following a further inspection, the scope of its licence and GMP dertification has been extended, and the company now has full regulatory authorisation to also perform in-house analytical testing of its challenge meal products, strengthening internal oversight across manufacturing and quality activities.
In preparation for the approval, Reacta has undertaken a significant expansion of its analytical capabilities.
This has included the establishment of new laboratory spaces, the purchase and qualification of analytical equipment, the development and extension of its pharmaceutical quality system to support in-house analysis, and the training of its team to carry out analytical testing to the required regulatory standards. Together, these activities ensure that the organisation is equipped to deliver analytical services within its own facilities in line with MHRA requirements.
