We manage & audit FDA clinical trials.

Our experts provide over 35 years verified experience on :

• New Drugs
• Generic Drugs
• Phase - I , II , III and post marketing phase IV

We have proven success in a myriad of therapeutic drug categories

as well as medical devices and combination products.

Our document development and management for FDA clinical trials include :

~ Clinical Protocol
~ Investigator’s Brochure
~ Clinical Audit Checklist
~ Regulatory Documents
~ FDA Preclinical Tests Summary
~ Pre-IND Meetings
~ Electronic Submissions
~ FDA Audits and Inspections

FDA clinical trials are difficult to

• set up
• manage
• audit and
• report successfully to investors and FDA.

You need an FDA consultant who knows the importance of timely and cost effective action.

Call us now at 248 747 8008 or email to info@regaffairs.net and

discover how we can help you right away.

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