Chairman and CEO, Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced that the European Commission and the centralized European Agency for the Evaluation of Medicinal Products (EMEA) has granted SME (Small and Medium Sized Enterprise) Status to Octagon Research Solutions Limited.
On 15 December 2005, the EMEA launched an “SME Office” focused on providing financial and administrative support to small and medium sized enterprises. This initiative was developed to promote innovation and encourage the development of new products by SMEs. Mark Turner, managing director, Europe, Octagon Research Solutions Limited, commented, ”SME status enables us to offer significant value as the regulatory agent for small organizations without a European Certificate of establishment or company infrastructure wishing to submit a Marketing Authorisation application in the European Union. As an existing SME, we can pass on reduced or deferred fees associated with Marketing Authorisation applications, scientific advice and inspections, eliminating the need for small companies not established in Europe to postpone product clinical and regulatory development or submission activities until they develop a European infrastructure in their own right.”
The SME initiative was based on a new European Commission Regulation (EC) No 2049/2005 which was adopted on 15 December 2005. In addition to fee reductions, exemptions and deferrals, administrative and procedural assistance is available from the SME office of the agency. Assistance with translation of product information documents submitted as part of the Marketing Authorisation application is also available to SME companies that are developing medicinal products for human or veterinary use.
Jim Walker, chairman and CEO of Octagon Research Solutions, Inc. noted, “We have had repeated success partnering with small and mid-size companies to meet their regulatory submission objectives. SME designation in Europe enables us to offer additional benefits to these organisations by facilitating the application procedure and taking advantage of agency support throughout the process.”
About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK.