DDN MEDICAL AFFAIRS OFFERS STRUCTURED PRODUCT LABELING (SPL) SERVICES TO THE LIFE SCIENCE INDUSTRY
Recent FDA Ruling Requires Conversion to SPL Electronic Format
MENOMONEE FALLS, Wis. – November 10, 2009 – In response to the June 1, 2009 FDA ruling that requires all establishment registrations, NDC labeler code requests, and drug listings be submitted using the SPL electronic format, DDN Medical Affairs now offers SPL services, assisting pharmaceutical companies with format conversion and compliance with the new requirements.
“SPL conversion and submission can be a complicated, frustrating and laborious process requiring training and a significant investment in time — even for seasoned professionals,” explains DDN Medical Affairs President, Carole DeRoche. “Our SPL specialists complete the conversion process on behalf of life science companies, allowing them to keep their staff focused on key priorities.” DeRoche said the DDN Medical Affairs solution ensures that content of labeling, establishment registration, labeler code requests and drug listings meet the new requirements quickly and accurately.
According to the FDA, Structured Product Labeling is a document markup standard approved by Health Level Seven (HL7) and adopted by the FDA as a mechanism to improve the flow of drug information to health care professionals and consumers. SPL documents contain the content of labeling (all text, tables and figures) for a product.
“Our SPL services are comprehensive,” said DeRoche, “We take care of drug establishment registrations labeler code request, and labeling conversions to new SPL requirements, after which we perform a quality review before submitting to FDA on our client’s behalf.”
About DDN Medical Affairs:
DDN Medical Affairs -- a member of the Dohmen family of companies -- offers medical and regulatory affairs support services for pharmaceutical, biotech and medical device companies. Established as a wholly-owned subsidiary of DDN, (which is a subsidiary of the 151-year-old Dohmen Company), DDN Medical Affairs is headquartered in Menomonee Falls, Wis. and provides medical and regulatory experience in preparing adverse event reports, product quality complaints and medical and technical product inquiries as well as labeling management. Visit us online at www.ddnmedicalaffairs.com for more information or call DDN Medical Affairs at 414.434.8400. You may also email Rob Klinck, Director of Business Development at RKlinck@ddnnet.com, or call Rob directly at 414.434.4651.