FDA Support

Fitzgerald Clinical Research offers strategy services with the ultimate goal of reaching FDA approval for your pharmaceutical, biologic, biosimilar, and medical device products. We possess experience collaborating on behalf of our sponsors with the FDA and help you prepare the required documents in advance of each meeting.

We also oversee regulatory consultants involved in assembling electronic submissions and can provide consultation for advisory meetings.

We can also provide clients with a comprehensive “FDA style” review of submission, assist with clinical testing protocols and assist with responses to FDA deficiency letters.

Contact us to discuss your need for FDA support.

FDA Submission Support
Briefing Documents Review
FDA Meetings:
Type A (Dispute resolution, Clinical holds, SPA, Post-action meetings)
Type B (Pre-IND, 505(b)(2), ANDA, EOP2, Pre-NDA, etc.)
Type C Advisory Committee Consultation
Briefing Documents
Investigator Brochure
Annual Reports