NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Jeanine Kuczik

Practice Area Focus

  • Regulatory Strategy
  • Nonclinical, CMC & Clinical Program Management
  • Project Management
  • Regulatory Submissions
  • FDA Interactions
  • Expert Witness Support

Biography

Jeanine Kuczik is a Partner, senior regulatory consultant and program manager for NDA Partners. She is the founder of JEK Pharma Consulting and provides regulatory strategy and submission oversight of IND/NDA/ANDA/505b2 and MAA regulatory filings. She routinely interfaces with FDA, often serving as a virtual regulatory affairs department. Recent projects have included NDA submissions in therapeutic areas including neurology, pain, psychiatry, urology, and cardiovascular products. She was previously in Pharmaceutical Development at Boehringer Ingelheim after which she held increasing roles of responsibility at Glaxo Inc in Regulatory Affairs and International Project Management.