(King of Prussia, PA; February 13, 2013) — Breaking into the world’s largest free-pricing market for pharmaceuticals may be easier than you think.
American regulatory affairs expert Brian Bollwage will present a live, interactive webinar titled “Coming to America: Regulatory Strategies for Foreign Drug and Device Companies” at 8 a.m. EST on Tuesday, Feb. 26.
“A lot of foreign companies are still reticent about seeking approval for their products in the U.S., when many of them needn’t be,” Bollwage said. “Regulatory pathways have been simplified and streamlined, and with proper guidance, many companies will find that U.S. approval is easier than they had imagined.”
Bollwage is a career regulatory professional with more than 30 years experience in the health products industry. He is currently the vice president of global regulatory affairs at Theorem Clinical Research and has served in the role of regulatory counsel at i3 Research and with Johnson & Johnson and Pharmacia, among others. He has managed the submissions of more than 150 INDs and 25 successful NDAs or BLAs.
Bollwage said the webinar will provide answers to specific questions about what it takes to get a drug or device approved for sale in the U.S. Participants will learn:
• How to apply for an exemption allowing you to conduct clinical trials
• The kinds of data you will need for different regulatory paths
• Specific advice on the guidance documentation supplied by regulatory agencies
• How and why to have a close working relationship with the FDA
Register for “Coming to America” to see how you can enter the U.S. market. Contact Theorem Clinical Research to learn more about its strategic regulatory affairs capabilities.
About Theorem Clinical Research
Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's leading pharmaceutical, biotech and medical device companies. A leader in medical device and drug-device combination trials in addition to a notable capability in pharmaceuticals and biologics, Theorem has deep expertise in a broad range of therapeutic areas and in all phases of development. Some of the industry's top scientists and most advanced clinical analytics capabilities help ensure smooth-running, successful trials. For a full-service, right-size global research partner, don't think twice. THINK THEOREM.