UK-based drug development specialist Quotient Bioresearch has boosted its early-phase credentials by gaining Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA).

The accreditation was awarded to the recently created strategic business unit, Quotient Clinical, and comes shortly after Quotient Bioresearch acquired an early-stage clinical research facility in Edinburgh, Scotland from Charles River Laboratories.

The Edinburgh facility, formerly known as Inveresk Clinical Research, gained its MHRA Supplementary Accreditation in January 2009. It has been combined with Pharmaceutical Profiles, the Nottingham-based provider of specialist Phase I drug development services acquired by Quotient last December, to form Quotient Clinical.

Now the consolidated unit has earned its Supplementary Accreditation stripes, meaning it is qualified to perform the full range of Phase I clinical trials, including first-in-human studies for low molecular-weight chemical entities and biologics.

Introduced in April 2008, the MHRA’s voluntary accreditation scheme for clinical trial units conducting Phase I studies was among the recommendations put forward in November 2006 by the final report of an Expert Scientific Group on Phase I trials, set up by the UK government in response to the disastrous first-in-man study of TeGenero’s monoclonal antibody TGN1412 at Northwick Park Hospital in London.

According to Quotient, the award represents “one of the highest levels of accreditation in Europe”.