CRANFORD, NJ – Paragon Solutions, an advisory consulting and systems integration firm, announces its Life Sciences Regulatory Optimization Practice will be showcasing its regulatory operations optimizations services and expertise at the DIA Regulatory Submissions, Information, and Document Management Forum, Feb. 8-10, 2016 at Bethesda North Marriott Hotel and Conference Center, North Bethesda, MD.
Paragon’s regulatory optimization services, which include regulatory readiness assessments, change management, cross functional standards and harmonization evaluations, system evaluation and procurement, regulatory intelligence, strategy and more, will be featured throughout the forum. The company’s expertise in Regulatory Affairs, Operations, Intelligence, and content management demonstrates the firm’s commitment and investment in providing industry leading support and guidance across all areas of Product Development and Lifecycle.
Paragon To Share Regulatory Intelligence
During the forum, Cary Smithson, Associate Director, Paragon Solutions, will present “Using the New DIA GMP Quality Systems Reference Models” on Wednesday, Feb. 10. The session will provide attendees information on the new DIA GMP Quality Systems and Labeling Reference Models that were developed by the Documents & Records Management Community.
Session topics will include an overview of the reference models and an interactive walk-through of the models, key considerations and best practices for adoption, as well as and a case study to highlight the experiences from a major pharmaceutical firm implementing the new GMP model. Smithson chairs the DIA GMP Quality Systems Reference Model Working Group, is a thought leader in regulated content and information management with more than 20 years of experience providing strategy, business process, and solution expertise life sciences.
Additionally, Paragon’s Associate Director, Brooke Casselberry, a member of the DIA Planning Committee, and Chair of the DIA Regulatory Intelligence Working Group, will be chairing several of the Regulatory Forum’s conference sessions. As regulatory subject matter expert with more than 15 years of experience in regulatory affairs and operations, Casselberry has led projects and initiatives involving more than 50 biopharmaceutical companies globally, contributing submissions, intelligence, management expertise and thought leadership.
About Paragon’s Regulatory Optimization Practice
Paragon Solutions’ Regulatory Optimization Practice has expertise crossing all areas of product development and post marketing activities: Regulatory, Clinical, Supply Chain and Manufacturing, Labeling, and Information Management. As a non-software client services organization, Paragon operates with complete non-bias in process development, system implementations, and vendor selection processes. During ISO Standards and Harmonization evaluations, we provide services as necessary for the organizations in which we are working while maintaining close communication for project efficiency through our Paragon ISO Task Force.
About Paragon Solutions
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance. Paragon Solutions works with businesses that are focused in a few key industries − communications, financial services, healthcare, insurance, and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in Process Optimization, Information Management, Information Governance and Information Integration.
For more information, please visit the Paragon at www.consultparagon.com, or call 1.800.462.5582.