Wilmington, DE, 22 January 2015 – Controlled Substance Compliance Services (CSCS), a project managed by the Pistoia Alliance, which helps companies check the legal requirements around using controlled substances in pharmaceutical research, is set to expand to China.
As their international operations expand and become increasingly complex, large pharma companies are globally adopting software solutions built as a result of the first phase of the CSCS project. When moving compounds across borders, there is a need to comply with regulations around the use of controlled substances in different regions and countries. By using these CSCS-inspired solutions, companies are easily able to manage the increasingly complicated regulations and ensure they remain fully compliant.
CSCS has set up an Expert Community to act as a forum for the exchange of information and the facilitation of expert debate. The CSCS Expert Community can be used to assist in researching particularly complicated regulatory requirements, helping its members to stay abreast of regulatory developments and maintain compliance. The Expert Community has recently identified the need to expand coverage into China and has been working with local partners to expand upon our existing expertise.
The CSCS project was created by the Pistoia Alliance; a global, not-for-profit alliance of life science companies, vendors, publishers, and academic groups that work together to lower barriers to innovation in R&D.
Claire Bellamy, project manager for CSCS at the Pistoia Alliance, said: “With increasing externalization and the importance of new markets such as China, the value of adopting CSCS solutions is growing. With commercial systems now available, and an expert community in place, CSCS is well placed to reach beyond Western markets.”
The Pistoia Alliance provided the interpretation of the legislation and encouraged the development of commercial products with shared risk funding from Astra Zeneca, GlaxoSmithKline, Merck, Novartis and Roche. The commercial products are available from Scitegrity and ChemAxon/PatCore.
Michael Braxenthaler, President of the Pistoia Alliance, added: “The success of CSCS shows the benefits of pre-competitive collaboration. CSCS solutions are now being adopted in the industry and its expansion into China shows just how effective the project is for helping companies remain compliant with complicated global regulations.”