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Gain a comprehensive view of EU regulatory affairs for pharmaceuticals and biologics during this two-day workshop. Essential regulations, directives, and guidelines affecting Europe's regulatory system will be covered, with specific focus on development considerations, clinical trials, marketing authorization applications, post-marketing requirements, and life-cycle management.
Improve how effectively you network and advocate for yourself with ideas and techniques from this on-demand webcast.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
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When developing a regional African regulatory strategy, it is very
important to make an early determination of the key markets that will be
targeted based on the size of country vs. medical need, time to
approval, competition, language, etc. This article addresses East and
Southern Africa, as they are major markets that often follow European
It’s generally nerve-wracking when the FDA shows up at your door for an inspection. Knowing what to expect can help.
The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products. View More
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products. View More
On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value. View More
In one of the most unusual Warning Letters sent by the US Food and Drug Administration (FDA) this year, a dietary supplement manufacturer has been chided by regulators for allegedly failing to allow an inspector to fully inspect the facility, allegedly because the products manufactured there contained an active ingredient also contained in Pfizer's Viagra. View More