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Take a proactive approach to ensure Regulatory Agency meeting success. It's part of a sound regulatory and business strategy.
Face-to-face meetings with Regulatory Agencies are a mission critical component of the regulatory review and approval process for new prescription drugs, biologics, medical devices and combination products. Meetings with regulators are opportunities to build trust in your development plan, regulatory strategy and scientific data. By employing the right resources and the right approach -- and avoiding some common pitfalls -- sponsors can take full advantage of the opportunities presented by Regulatory Agency meetings to expedite the review process and help their products reach the market more quickly.
Despite the significant potential value of these meetings, many companies do not take full advantage and thereby increase the time and expense to market. Let PAREXEL Consulting experts, including ex-Agency and industry professionals, guide you with insight into the latest Agency opinions and regulations, help you devise regulatory meeting strategy and plans, conduct data reviews, conduct briefing document preparation and meeting rehearsals, and prepare follow-up responses.
For US development activities, our new Bethesda, MD offices are available for meeting preparation in close proximity to FDA locations. Sponsor teams can gather prior to FDA meetings and for post meeting debriefs and response activities. Both U.S. based and International companies alike have valued this service for helping to advance their development process, and the convenience it offers in the Washington, DC area.
In Europe, we have over 25 years experience working at the National and European (EMEA) agency levels. We are located strategically throughout Europe to assist you.
In Latin America, Canada, Asia Pacific, India, South Africa we can assist with both in-country and rest-of-world regulatory affairs and agency meetings.