Aclairo® consultants are experts in FDA regulations and guidelines and provide insight into current regulatory interpretation at the FDA. We support clients in their FDA interactions through written documents, oral communication, and face-to-face meetings.

• Regulatory due diligence
• Critical review and gap analysis of regulations
• 505(b)(2) strategies
• FDA correspondence interpretation and regulatory guidance
• FDA meeting and teleconference participation
• Regulatory meeting coaching and preparation

For more information, please contact: Dana Dunn (ddunn@aclairo.com)