Jeanine Kuczik is Manager and Premier Expert for NDA Partners. Jeanine Kuczik is 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. Regulatory Affairs and International Project Management Division.