John Misock As an accomplished leader across multiple FDA-regulated industries, John uses his broad experience to help clients obtain the best possible outcomes when faced with regulatory challenges. John’s ability to get to the heart of the matter gets quick, accurate, and cost-saving results.

Whether responding to FDA warning letters or instituting a corporate-wide QMS, John’s previous FDA experience provides a unique perspective on compliance with regulatory requirements. His understanding of the FDA’s prior approval processes for drugs and devices would be an asset to any firm considering marketing new or rebranded products.

Expertise
• Regulatory compliance
• QMS
• NDA/ANDA
• IND
• 501k
• International regulatory compliance, ICH, MDR