MLC, LLC Consultant

I have had the pleasure of working with Kelsey McCormick on several different regulatory affairs Consulting projects for both small and large biopharmaceutical companies. In these endeavors, I have found Kelsey to be extremely professional, knowledgeable about FDA document requirements and well-focused on providing the best possible services to her clients, consistent with their budget and schedule requirements. Kelsey has also established a strong network of affiliate Consultants that work closely with her to provide expertise and technical capabilities that complement her core strengths in regulatory affairs and medical writing. I can strongly recommend Kelsey and Mccormick LifeScience Consultants, LLC (www.MLC, LLCcormickconsulting.com) to anyone needing US regulatory affairs and medical writing Consultant services. Bill M, Ph.D., RAC, Director of Regulatory Affairs,
Sr Principal Consultant

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

Kelsey’s knowledge of current regulatory filing practices including CTD formatting and module organization contributed to many successful US and worldwide Regulatory filings. Kelsey’s integrity, work ethics and professionalism are outstanding and resulted in meeting aggressive filing timelines while maintaining a cohesive teamwork approach. David O., Ph.D.,
Research Manager

Do you want somebody who consistently produces high quality work in a timely manner? Do you need somebody that can provide real Regulatory project leadership? Are you looking for a consultant with extensive knowledge and with high ethical standards? I have worked with Kelsey and if your answer yes to all or any of the above questions, she is the person you need to hire. Alonso G.,
Associate Consultant

Kelsey is a highly talented professional that truly understands all aspects of her clients needs. She is someone that is truly unique in her abilities to network and understand, create opportunities that others like herself may not. I look forward to future collaborations with Kelsey. Geoff H.,
Account Manager

Kelsey is an organized and detail-oriented Regulatory and medical writing consultant who exhibits a high level of professionalism. Deadlines are met and documents etc. are prepared according to the highest standards. She is flexible and offers a broad range of expertise. Kelsey goes above and beyond to provide her clients with an excellent product. Marcie R., Ph.D.,
Consultant

Kelsey’s quality of work and willingness to contribute to our overall effort in preparation for a strategic regulatory submission were consistently of high quality. Her ability to adapt to our internal team and provide timely and thoughtful contributions is a clear indication of her dedication to her clients. Dwight D.,
Operations Director

Kelsey is a very detail-oriented manger who keeps track of projects that are assigned to her. She is very professional and meets all deadlines. Her work is very high level and her valuable knowledge makes her an asset to any company. Her extensive experience gives her a broad range in different parts of submissions; she is truly a hard working colleague. Elizabeth M.,
Dossier Planning and Management

Ms. Kelsey McCormick has consistently produced high quality work in a timely manner.  She demonstrates a high level of performance in her work and has established herself as an excellent Regulatory Affairs Professional.  Her work ethic and collaboration are truly her greatest strengths. Jeffrey B.,
Regulatory Affairs Manager

I've known Kelsey for over five years now.  She has a great personality that makes working with her an absolute pleasure.  Her work ethic is commendable; she is a very self-motivated, dependable and confident person willing to do what it takes to get the job done. Darlene R.,
Owner

Kelsey is very professional and meets deadlines; her expertise in the industry and Master’s degree in Regulatory Affairs are valuable assets.  I would recommend her to any company that needs her type of experience. Darlene M., MS  Director
Quality Assurance/Regulatory Affairs

Kelsey is a truly dedicated, hard working, conscientious professional who takes pride in all assignments. Mahesh M., Ph.D.
Principal Investigator