Oral food challenge (OFC) material manufacturer Reacta Healthcare has announced that the MHRA has renewed and extended its Manufacturer’s Licence and GMP Certificate.
The company has held an MHRA Manufacturer's Licence for the past five years.
Following an inspection, the MHRA extended the scope of Reacta's Licence and GMP Certification, granting it full regulatory authorisation to perform in-house analytical testing of its challenge meal products, thereby strengthening internal oversight across manufacturing and quality activities.
Reacta said in a statement that prior to the approval, it had undertaken a significant expansion of its analytical capabilities, including the establishment of new laboratory spaces, purchasing and qualification of analytical equipment, developing and extending 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.
Paul Abrahams, CEO of Reacta Healthcare, said: "I am grateful to the team for all the hard work and commitment that went into preparing for our inspection and for ensuring that it was a success."
"We believe we are the only oral food challenge (OFC) supplier manufacturing to full pharmaceutical GMP standard and operating worldwide."
This extended certification by the MHRA further strengthens our position as a specialist partner in the development and manufacture of OFC materials for clinical trials, contributing to the advancement of food allergy research globally.
Jan Philips, Head of Quality at Reacta Healthcare, added: "This is a significant milestone for Reacta and reflects the continued investment, commitment and hard work across our business to maintain the highest regulatory and compliance standards."
By bringing analytical testing in-house, we can offer our customers further operational efficiency, strengthened quality assurance and increased responsiveness in supporting their clinical development programmes.