Regulatory Affairs

Amarex has a special and unique insight into the workings, procedures, and requirements of the FDA. This unique insight comes from years of experience working for and with the FDA.

This insight, together with our successful experiences in completing all phases of clinical trials from design through submission, successful defense, approval of several U.S. NDAs, PMAs, and European Marketing Applications, afford Amarex the knowledge and experience to successfully guide your project from concept through completion.

We know how critical it is to assure a sound regulatory strategy, trial design, and regulatory communication from the concept stage of a clinical trial. Our team is comprised of regulatory professionals with many years of experience
either working for or with the FDA. Team members have years of drug and device development experience. Our experts have presented to more than 30 FDA advisory committees both as FDA representatives and as sponsor representatives. They have worked on numerous NDAs, PMAs, 510Ks, representing different classes of drugs and devices.

AMAREX expertise, in conjunction with your staff’s expertise, ensure desired product approval and product labeling through the appropriate studies. We work with you in developing proper documentation and integrated reports to establish the safety and efficacy of your product.

Amarex Regulatory Affairs Services:

• Site Audits
• Contract Research Organization Audits
• Standard Operating Procedure Development
• Regulatory submissions
• U.S. Food and Drug Administration contact
• Serious Adverse Event Reporting