PRE-APPROVAL AUDITS:

• Let us help you prepare for FDA inspection

 

CLINICAL STUDY DESIGN TAILORED TO YOUR PROJECT REQUIREMENTS

• Let us help you write: Clinical Protocols, Case Report Forms (CRFs), the Label, Informed Consent Forms, Patient Packet Inserts (PPI)
• We will advise on Data Safety Monitoring Board. Do you need one? How to convene one.
• We will help you get that first patient into the clinical study, reviewing data for FDA approvability, IND, IDE

 

FDA SUBMISSION

• We will review and evaluate your clinical program for FDA filing
• We will assist in the preparation of: IND, NDA; IDE, PMA, 510(k); Drug/Device and Biologic/Device Submission
• Safety Reviews
• Adverse Event Report Reviews
• Review and Evaluate ISS and IES; Integrated Safety Summary; Integrated Efficacy Summary
• Risk Benefit

 

REGULATORY STRATEGY

• We will identify Regulatory Issues in your submission; work with you on solutions to issues; prepare your team to negotiate with FDA; interpret FDA regulations, guidelines, and policies

 

PREPARATION FOR MEETINGS

• Participate at investigator meetings to help insure compliance with protocol (non-compliance can be costly).
• Prepare companies to meet with FDA staff at any stage of development
• Prepare for FDA Advisory Panels

GOOD CLINICAL PRACTICES (GCP) REVIEWS

• Assess your program on or off site for FDA compliance
• Recommend corrective action for implementation

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