MLC, LLC Consultant
Groton, MA 01450 Phone: 978.448.0953Email: kelsey@mccormicklifescience.com
Who We Are > About the Founder
Kelsey McCormick, M.S. has been in the Pharmaceutical industry for greater than 10 years. In 2000, Kelsey earned her Bachelor's of Science degree in Veterinary Medicine from Quinnipiac University in Hamden, CT. She then initiated her professional career in the Discovery Biology group at Bristol-Myers Squibb Medical Imaging (BMS-MI) in North Billerica, MA as an in vivo pharmacologist. She concentrated in areas of Oncology and Cardiology (study planning, study implementation, data compilation, and protocol/report drafting). In 2003, Kelsey obtained her Master's of Science degree in Regulatory Affairs from the Massachusetts College of Pharmacy and Health Sciences in Boston, MA. In addition to her role as an in vivo pharmacologist, Kelsey became the liaison between the Discovery Biology group and the Regulatory Affairs group at BMS-MI. Included in her job functions were drafting, reviewing, and coordinating the Nonclinical portions of all BMS-MI internal documentation and Regulatory submissions. Kelsey also assisted other functional groups in the Regulatory submission process.
With this experience, in early 2007, Kelsey formed her own LLC in the Pharmaceutical/ Biotechnology/Medical Device Consulting field. K McCormick Consulting, LLC (KMC, LLC) engaged in multiple client projects including (but not limited to), Regulatory management, FDA correspondence, submission writing, review, coordination, & publishing, ICH CTD training and implementation, nonclinical and clinical medical writing, and report audits (toxicology, CMC). Kelsey holds a superior track record of coordinating, compiling and publishing high quality and timely reports and submissions for FDA and global Regulatory Authority review (IND/CTA/IMPD, NDA/MAA, 505(b)(2), Orphan Applications, IB, PI, Pre-Meeting and Meeting packages, Annual Reports, Expert reports, Clinical Study Reports, etc.), efficient development and implementation of in vivo models, and well-organized proven processes for writing and review of protocols, study reports and submissions within deadline parameters.
In mid-2009, KMC, LLC’s growth led to a company expansion/re-branding, in which Kelsey formed, McCormick LifeScience Consultants, LLC. MLC, LLC now provides greater capabilities with an expanded team of expert consultants and a wide variety of product development services. Incorporated into MLC, LLC are industry professionals that can answer all of your company's needs with our expertise in Nonclinical, Clinical, Regulatory, CMC, Quality Assurance/GXP compliance, intellectual property, advanced literature searches, and training.
Kelsey remains closely involved with her client projects and spends much of her time managing the business, networking/marketing and with business development efforts.
Kelsey McCormick’s Professional Affiliations:
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Bridging the gap between discovery and market with efficient execution of the approval process
"I have worked with Kelsey for most of the past year on an IND project for a small, local biotechnology company with very limited resources. She has provided regulatory project leadership, including guiding content contributors, writing content herself, and keeping all aspects of the pre-IND and IND process on track. Kelsey is a consummate regulatory professional, and has become a trusted, and vital member of the team. Her contributions have extended the resources of the sponsor company, allowing them to focus on long-term strategy and in-house expertise development. I would heartily recommend Kelsey's services to drug, device and biologics companies needing regulatory guidance, writing, project management and submission preparation."
David M., Ph.D.,
VP of Regulatory Affairs
