We help medical device, pharmaceutical, biotech and combination product companies meet your objectives by formulating regulatory strategies that take into account your target product goals, markets, and time frames.  Through his extensive background at FDA and in regulated industry, Mark has the knowledge and real-world experience to help companies navigate the increasingly complex global regulatory environment.  Mark's consulting practice includes the following types of services:


  • Develop regulatory strategies to obtain and/or maintain medical product approval/clearance
  • Recommend optimal path to determine product jurisdiction for combination products and single-entity products 
  • Prepare premarket submissions and responses to Agency questions (IDE, 510(k), PMA, IND, NDA, pre-submissions)
  • Prepare for Agency meetings 
  • Navigate the complex premarket, postmarket and compliance regulatory requirements for combination products
  • ​CGMP requirements for combination products (21 CFR 4)
  • ​Postmarket safety (adverse event) reporting requirements for combination products (21 CFR 4)
  • Monitor, interpret and analyze the impact of the evolving regulatory landscape
  • Litigation/expert witness support​
  • Due diligence activities
  • Assess regulatory compliance and impact of promotional and advertising materials
  • Advisory panel/committee preparation
  • Prepare responses to 483's and/or warning letters
  • Review investigational plans/protocols
  • Conduct data audits
REgulator​y Strategies, Inc.
SERVICES

Mark D. Kramer

Consulting