All Apyx project managers are fully knowledgeable in eCTD including all applicable multinational regulations.
Apyx executives are recognized as among the top few eCTD Subject Matter Experts in the industry, speaking frequently at industry conferences both nationally and internationally including the DIA EDM, DIA Annual Meeting and eCTD conferences.
CEO Ken VanLuvanee is actively involved in developing the evolving RPS submission publishing standard and is also an active HL7 member.
Ken VanLuvanee
Ken VanLuvanee is CEO, President and Founder of Apyx, Inc. Ken has worked in the life sciences industry for more than 18 years and has helped define and lead efforts within Regulatory Affairs, Medical Affairs, Clinical and Pharmacovigilance areas of the industry related to efficient, compliant use and management of controlled documents.
Ken is a globally recognized expert in electronic document management and electronic publishing and has both participated in and managed global publishing teams in the creation of submissions in multiple paper and electronic formats to multinational health authorities. He was invited to participate in the RPS working group sponsored by Health Level 7 (HL7), an FDA sponsored and ANSII accredited standards development organization charged with developing a future standard for transmission of electronic information between healthcare companies and global regulatory agencies.
Ken is active within DIA, with leadership and involvement in multiple Special Interest Activity Communities (SIACs), including the Regulatory Submission Publishing SIAC and the Records Management and Archiving SIAC, as well as the Electronic Document Management Reference Model working group.
Ken also speaks widely throughout the industry at DIA and other events.
Stacy J. Tegan
Stacy is the Director of Dossier Management and Publishing at Apyx. She is responsible for Apyx publishing operations for original application and lifecycle submissions as well as QA activities including development of SOPs and Working Practices. She manages a team of publishing experts well versed in eCTD and submission standards who provide clients with project management and submissions support services. Stacy joined Apyx in 2003 as a Regulatory Business Analyst.
Stacy's career in the pharmaceutical industry began in 1996 and she has served as project manager at multiple pharmaceutical companies including Sanofi and Centocor. In these positions she was responsible for establishing a publishing department with full eCTD capabilities, leading an electronic submissions technology validation initiative and QA activities.
Stacy maintains in-depth technical knowledge of FDA and ICH submission requirements and has extensive publishing expertise in industry standard systems and emerging software. She is active in the industry and has spoken at numerous conferences.
Stacy holds a Bachelor of Science from the Pennsylvania State University.
Mike Bradly
Mike Bradly serves as Director of Sales and Marketing at Apyx and is responsible for increasing company sales and driving the company's marketing and business development strategy. Mike is also responsible for customer support strategy and management of the sales team. Mike joined Apyx in 2004 as a Sales Account Manager.
Prior to joining Apyx, Mike served as a Business Development Manager for DataCore Technology, a technology and services company focused on providing IT solutions to pharmaceutical and other vertical markets.
Earlier in his career, Mike held sales positions at Innovative Consulting, a technology consulting firm specializing in the delivery of business intelligence consulting services and Kforce.com.
Mike holds a Bachelor of Science in Business from the University of Vermont.
Sean Carpenter
Sean is the Director of Information Technology at Apyx. He is responsible for the strategy and implementation of the company's IT infrastructure and is the owner of Apyx's technology solutions: SPL Manager, Annotation Manager and CTD Authoring Templates. He has been the Director of Information Technology since late 2005.
Sean joined Apyx to design and create a solution for Structured Product Labeling (SPL), at the time a new electronic initiative from FDA. Since then, and in addition to managing the ongoing development and support of Apyx technology solutions, Sean has added ownership of all Apyx products and IT services to his responsibilities. Sean holds a Bachelors of Science degree from the Pennsylvania State University.
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.