PRE-APPROVAL AUDITS:

•  Mock FDA Inspection
•  Prepare for FDA inspection
• Clinical QA (Quality Assurance) Audit 
• GCP (Good Clinical Practice) Compliance audit

 

CLINICAL STUDY DESIGN TAILORED TO YOUR PROJECT REQUIREMENTS

• Write Clinical Protocols, Case Report Forms (CRFs), the Label, Informed Consent Forms, Patient Packet Inserts (PPI)
• Advise on Data Safety Monitoring Committee. Do you need one? How to convene one.
• Get that first patient into the clinical study, reviewing data for FDA approvability, IND, IDE

 

FDA SUBMISSION

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