WAYNE, Pa.--(BUSINESS WIRE)--Octagon Research Solutions, Inc., the leader in transforming clinical R&D through an integrated suite of regulatory, clinical, process and technology solutions, announced today that Gina L. Schmidt, an industry expert in global eCTD and electronic regulatory submission filing strategies has joined the Octagon team. As Executive Vice President, Ms. Schmidt will lead and manage Octagon’s Global Regulatory Submissions services line of business.
With more than 20 years industry experience, Ms. Schmidt was previously Vice President, Worldwide Safety and Regulatory Operations at Pfizer, Inc. In this role she was responsible for the global oversight of the Submissions and Product License Support activities for the Pfizer portfolio.
“We are pleased to welcome Gina to Octagon as Executive Vice President of Global Regulatory Submission Management,” said James C. Walker, Chairman and CEO, Octagon Research Solutions Inc. “She brings a wide range of industry knowledge that will assist us in strategically broadening and growing our regulatory service solutions on a global scale.”
Ms. Schmidt’s background complements Octagon’s industry-leading capabilities and expertise in helping companies across all tiers gain efficiencies throughout the clinical data and regulatory information continuum. To date, Octagon has completed thousands of submissions including more than 350 original applications in the U.S., Canada, Europe, Australia, South Africa, New Zealand, Korea, Russia, India, Singapore and Ukraine. In 2011, Octagon grew its global capabilities with expanded operations in Europe and India, all while adding more jobs at its US headquarters.
“It is critical to the success of our clients that Octagon continues to provide strategic insights that help all tiers of industry gain efficiencies and adopt global standards. Gina’s leadership and expertise will provide a significant contribution to this objective,” said Kirk Gallion, President, Octagon Research Solutions, Inc.
“Octagon is changing the landscape of regulatory information management within the global bioscience services industry, and I am very excited to be a part of this growing and dynamic company,” said Ms. Schmidt. “Hundreds of companies worldwide depend upon this organization, and I look forward to adding my professional capabilities to enforce its already sterling reputation.”
About Octagon Research Solutions, Inc.
Octagon is the industry leader in transforming clinical R&D through an integrated suite of regulatory, clinical, process and technology solutions. With a foundation in data standards and advanced technology, Octagon’s eCTD and CDISC-enabled solutions provide all of the resources required to optimize drug development from data collection to submission. Octagon’s unique combination of deep domain knowledge, cross-functional electronic submission expertise and holistic process approach utilizing integrated solutions, set us apart as we serve more than 400 clients on three continents. Our global headquarters are in Wayne, Pennsylvania with additional US offices in Mountain View, California. Octagon also has European offices based in London, UK, and Asia-Pacific offices in Bangalore, India. For more information, visit www.octagonresearch.com.