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UK Centre to "fast-track" regulatory Response
Posted on October 18, 2006
A leading US consulting firm specialising in chemical product approval, support and regulatory defence has launched a European operation to help industry tackle the 'intimidating landscape' of increasing regulation in the region.
The Acta Group EU, Ltd has opened a centre near Manchester, UK, with a team of specialists in product registration, regulatory issues and toxicology as a 'centre of expertise' for industry. The firm's experience covers the chemical, agochemical, biocide, biotechnology and nanotechnology sectors and also medical devices.
"Regardless of a product's efficacy and economics, our industry's biggest challenge in developing new markets and supporting existing portfolios are regulatory issues. One mistake can sink a project in a moment," comments Lynn Bergeson, the head of Acta in Washington DC and a lawyer who has more than 20 years experience in this sector.
The company already works with many of the US-based majors and the European move has been prompted in part by the increasing challenges international businesses encounter in EU markets - most recently the European's REACH regulatory framework (Registration, Evaluation and Authorisation of Chemicals).
"The spiralling costs and inefficiencies of regulatory systems make Europe an intimidating landscape in which to operate. Our role is to navigate through this minefield and get products to market more quickly and defend existing positions for our customers," she added.
The Acta regulatory team provide project management to fast-track product approval and registration and to build support and defence packages for product portfolios. Toxicology specialists compile supporting data packages including literature searches, reviews and risk assessments.
Julie Dodd, regulatory manager of Acta Group EU, commented. "We have expertise in the EU and a wealth of experience to draw on from our colleagues in the US. We aim to form a focal point for chemical and related industries to tackle the regulatory issues together, efficiently. The REACH framework is going to put this requirement to the top of the agenda for many companies marketing in Europe," she said.
In addition to assisting industry with REACH, Acta Group expects to focus on supporting the registration and approval of agrochemicals products and defending actives in the EU Review process. Nanotechnology is an important, emerging field where Acta will work to support and protect the industry's operational flexibility as authorities begin to develop regulatory frameworks for the sector.
Acta Group EU is based at The Heath Technology Park in Runcorn, near Manchester, in the heart of the UK chemical industry. The key personnel are Regulatory Managers Julie Dodd and Dr Alison Bartlett, and Business Development Manager, Steven Green.
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