PHILADELPHIA, Aug. 16, 2012 /PRNewswire/ -- GlobalSubmit Inc., (www.globalsubmit.com) a leading developer of software designed exclusively to publish, validate, and review electronic Common Technical Document (eCTD) global submissions, announces the expansion of its service offerings with the opening of an office and key new hire in San Diego, CA.
Under the direction of Emily Onkka, Director of Project Management and Regulatory Operations, the new office will increase GlobalSubmit's ability to provide professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Utilizing the latest technologies, including GlobalSubmit CLOUD, both the San Diego office and the Philadelphia headquarters can seamlessly work on projects to support both existing as well as new clients.
Ms. Onkka continues GlobalSubmit's tradition of thought leadership having over 10 years of electronic submission experience. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations and Document Management at Ardea Biosciences, Inc. where she was responsible for leading the implementation of electronic submission capabilities as well as planning and generating eCTD submissions, among other duties that will serve her well in this new role.
Rahul Mistry, GlobalSubmit's CEO said, "The opening of our new San Diego office stems from a growth in our regulatory operations and publishing services. As many companies are narrowing their vendor lists, and the vendor community continues to consolidate, GlobalSubmit has increasingly been asked to take a larger outsourcing role within our clients. We welcome the depth of talent and experience that Emily will bring to our team, and look forward to a continued expansion of services and an increase in clients as smaller companies continue to adopt electronic submissions."
Ms. Onkka commented, "I am very excited to join an industry-leading company during a time of such tremendous growth, and I look forward to the opportunities ahead. The reputation of GlobalSubmit's product and services are second to none. I plan to leverage my unique background to fit the strategic direction of the company while working to ensure the success of GlobalSubmit's eCTD professional services."
GlobalSubmit is a products and services company that provides transparency in regulated healthcare products. The U.S. Food & Drug Administration and leading Life Sciences companies use our flagship software applications, REVIEW™ and VALIDATE™, to review and validate electronic submissions. GlobalSubmit's thought leaders lead international efforts, constantly working with the industry and with government agencies to standardize product and study information. The company is headquartered in Philadelphia, Pennsylvania.
SOURCE GlobalSubmit Inc.