reacta-mhra-licence-analytical-testing

Reacta Healthcare has received an extension to its Manufacturer’s Licence and Good Manufacturing Practice certification from the UK Medicines & Healthcare products Regulatory Agency, enabling the company to carry out in-house analytical testing of its pharmaceutical-grade oral food challenge products.

The updated authorisation expands the scope of Reacta’s existing MHRA licence, which it has held for the past five years, following a further regulatory inspection. The company said the change strengthens oversight of its manufacturing and quality operations by allowing analytical testing to be performed within its own facilities.

Reacta develops and manufactures oral food challenge products used in food allergy diagnostics and clinical research. According to the company, the enhanced certification supports its ability to provide manufacturing and quality services from a single site while meeting pharmaceutical GMP requirements.

To prepare for the expanded licence, Reacta invested in new laboratory facilities, analytical equipment and staff training, while extending its pharmaceutical quality system to support in-house testing activities. The company said these measures were implemented to satisfy MHRA regulatory standards and ensure analytical services could be delivered internally.

Paul Abrahams, chief executive officer 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.”

He added: “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.”

Bringing analytical testing in-house could reduce reliance on external laboratories and improve turnaround times for quality assurance activities, while giving the company greater control over testing processes during product manufacture.

Jan Philips, head of quality at Reacta Healthcare, said: “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.”

He added: “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.”

The renewed and expanded certification comes as pharmaceutical manufacturers continue to invest in integrated quality systems designed to streamline development and production activities while meeting increasingly stringent regulatory expectations. For companies supplying materials used in food allergy research and clinical trials, the ability to conduct manufacturing and analytical testing under one quality framework may help support consistency and regulatory compliance throughout the development process.