The US-based contract research organisation (CRO) will now offer its DRS consulting services to support pharma firms in the discovery and development of their new drugs and biologics in EU markets. The firm offers global regulatory support for drug, biological and medical device products in preclinical development through post-approval surveillance and marketing, including regulatory consulting, preparation of regulatory submissions and global regulatory liaison. In addition, it provides pharma clients with development services for their research process for small and large molecule drugs from lead identification through clinical proof-of-concept, to full clinical development. MDS said its European DRS organisation will also be fully integrated with consultants in the US and Canada to provide product development consulting, programme management, and regulatory affairs services. "This expansion in Europe will greatly broaden our consulting capabilities in development and regulatory services," said MDS Pharma Services president David Spaight. "We will now be able to provide expertise to support our biotechnology and pharmaceutical clients in the process of commercialising their products in North American and European markets." To support the expansion, the company has made two new appointments in its management team. MDS is trying to refocus its effort on this business in a bid to offset the recent difficulties it has been facing in its bioanalytical business which is still dragging down the company's financial results. The firm was hit by a restructuring charge of $26m (€19m) in the second quarter of the year and suffered a 12 per cent decline in its early-stage segment, "which continues to feel the impact of FDA-related issues at our Montreal site", the company said. MDS Pharma said in June it will use these funds to consolidate its North American bioanalytical LC/MS operations into its Nebraska, US site and refocus its Montreal, Canada site on early clinical research, ligand binding services and DRS. In May MDS decided to put an end to some activities at its Montreal facility, cutting 160 jobs, just three months after undertaking a similar scale-back process with its Quebec City plant. The company's two bioanalytical facilities in Canada have been under scrutiny by the FDA after inspections by the regulator in 2003 found a range of problems with its pharmacokinetics testing procedures, including failure to identify and fix sources of contamination in bioanalytical tests, which measured drug levels in the blood of patients. As a result, the FDA began a review in February 2005 of all the bioequivalence tests performed by the pharma services unit of MDS between 2000 and 2004, and in September last year, MDS voluntarily suspended its LC/MS services in order to undertake its own internal review. MDS said it has now completed approximately 70 per cent of the audits for its bioanalytical clients which cost the company an extra $61m in the quarter to fund the completion of these activities. The company said it expects to have the FDA audits "substantially complete by the end of 2007."
