waxlerfda.com
Waxler Regulatory Consultancy LLCWaxler Regulatory Consultancy LLC. 1920 Arlington Place, Madison, WI 53726 (608) 219-7547 mwaxler@charter.net. Click to enlarge.). I provide consultant services on Food and Drug Agency regulatory issues for the entire life cycle of your medical devices including, but not limited to:. Is your product regulated by FDA? Is your product regulated as a device, a drug, a biologic, or some combination? Do you need pre-market authorization from FDA? What kind of pre-market authorization is required? Completed fi...
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