Europe's leading contract research and consulting organisation, RCC Ltd has made an entry into growing contract research business in India. The Switzerland-based CRO major has already set up its liaison office at Ahmedabad and would be looking at the internationally relevant drug development projects originating as well as tried in India. RCC Ltd with staff strength of 620 at facilities in Switzerland and Germany would give thrust on projects driven with its 'fast-into man' drug development concept.
While speaking to Pharmabiz.com, Bina Ramani, India liaison officer, RCC Ltd, said that the CRO could cater to globally relevant projects from India using new techniques in line with advances in regulatory thinking and requirements. RCC's core capabilities at present are in toxicology, genotoxicity/ cytotoxicity, pharmacology, kinetics/ADME, pharmaceutical quality control, analytical chemistry, ecotoxicology, environmental fate, animal breeding, transgenic technology and regulatory affairs and consulting.
Currently, RCC Ltd has five semi-autonomous operating divisions enabling each to be more flexible and responsive to client requirements mainly focussing at toxicology, environmental chemistry and pharmanalytics, registration and consulting, biotechnology and animal breeding, genetic toxicology and cell biology and IT-systems & software development. According to RCC sources, since India is emerging as one of the most ideal locations in the world for clinical research and drug development, the company foresees a major boost in its projects at this part of the globe where the latest technologies and expertise that the company has developed over the years to perform all aspects of health and environmental safety testing can be used.
Bina added that as a globally experienced CRO, RCC can understand the commercial realities of successful product development, and so its efforts are focused on constant progress towards a market launch. At the outset, its team of industry-specific specialists plan the most efficient programme of work to achieve marketing authorisation, she said. In India, the company looks for forging successful partnerships with research-based companies of all sizes in all major sectors of the chemical, pharmaceutical and biotechnology industries. RCC's client list at present extends from the largest multinational corporations to small dynamic start-up biotechnology companies in the areas pharmaceuticals, agrochemicals, consumer products, chemicals, fibers, medical devices, food packaging materials, food/feed additives, biocides etc.
RCC provides an integrated service from strategic planning, through project perfor-mance, to dossier preparation for clinical trial authorisation or product registration. This integrated approach is incorporated into our 'fast-into man' drug development concept. Alternatively, any of our regulatory and testing services can be mobilised quickly, on a single project basis, to complement in-house capacity or to provide specialist expertise. RCC studies are performed according to international GLP guidelines in laboratories regularly inspected and certified by Swiss or German government authorities. Official inspections are undertaken in accordance with the OECD guidelines for national GLP inspections and study audits.
Besides, the mutual agreement reached between Japan and Switzerland ensures that all RCC studies are fully and readily acceptable to Japanese government authorities. A memorandum of understanding concluded between Switzerland and the USA ensures similar acceptance by US government authorities and it works in compliance with GMP for the performance of analyses of pharmaceutical products. At present, RCC is accredited as a testing laboratory according to the European Standard EN ISO/IEC 17025 and as a certification body providing product certificates according to EN 45011. RCC is accredited By AAALAC, the Association for the Assessment and Accreditation of Laboratory Animal Care, the company sources said.