Waxler Regulatory Consultancy LLC

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1920 Arlington Place, Madison, WI 53726 (608) 219-7547  mwaxler@charter.net

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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?
  • Are you in compliance with Design Controls and other aspects of FDA Quality Regulations?
  • Are your claims for your product within the bounds of the product classification?
  • Has the agency cited your company for deficiencies?
  • Are your complaint handling processes and procedures compliant?
  • Do you have an FDA inspection process?

Our services include:
 
    • Assessment of FDA component of business plans.
    • Preparation and review of premarket applications.
    • Review of adequacy of Design Controls.
    • Preparation and gap analysis of compliance with Quality System Regulations.
    • Preparation for meetings with the agency.
    • Opinion letters regarding regulatory status of your products.
We provide FREE ESTIMATES...give us a call.

Resume
 
  • Founded Waxler Regulatory Consultancy LLC in 2008 to continue my practice of providing FDA regulatory advice after 26 years at FDA and nearly 7 years at law firms.
  • Completed five successful years with the FDA Consulting Practice at Godfrey & Kahn, a law firm in Madison, WI.  Formulated regulatory strategies for a wide range of medical products including cardiovascular implants, combination products, ophthalmic devices, and antibiotic biologics.  Also served for six months as compliance officer for a major manufacturer of cardiovascular devices to assure compliance with a Corporate Integrity Agreement with the Department of Health and Human Services.
  • Successfully formulated and implemented regulatory strategies for more than 60 manufacturers of a wide range of medical products in 22 months at Hogan & Hartson, a law firm in Washington, DC and elsewhere.  The products included demineralized human bone, human cultured skin, tissue-based wound dressings, vascular and biliary stents, orthopedic and spinal implants, reagents, and many other products.
  • Four years as an innovative manager at FDA regulating eye, ear, nose and throat devices.
  • Successfully developed consensus within FDA on regulatory, engineering, and clinical guidance for manufacturers seeking marketing approval of lasers for refractive surgery (LASIK).
  • Eighteen years of successful facilitation of organizational transitions with FDA.
  • Two years experience successfully mediating workplace disputes with the Federal government.


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Waxler Regulatory Consultancy LLC
1920 Arlington Place
Madison, WI 53726
608-219-7547

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