Randall Carpenter, MDCEO / Seaside Therapeutics
My company has worked closely and continuously with Kelsey over the past six years. During the initial years, Kelsey provided regulatory project leadership and assumed responsibility for regulatory affairs/operations to support opening two IND’s. More recently, as McCormick LifeScience Consultants has expanded capabilities, we have expanded our relationship to take advantage of her team’s expertise in a range of other areas including intellectual property and pharmacovigilance. Kelsey has broad expertise, is incredibly competent and is a consummate professional. What really sets Kelsey apart however is that she truly considers herself, and has become, an integral member of our team. She is always fully engaged and aligned with our goals. Drug development is never a linear process and we are incredibly fortunate, when the unexpected event leads to crunch time, to have McCormick LifeScience Consultants, LLC on our team.
Seth Finklestein, MDCEO / Biotrofix
We have worked with McCormick LifeScience Consultants, LLC for the last year and have found this relationship to be extremely beneficial and cost-effective. Kelsey and her consultants are both highly expert and collegial. We have used their services in implementing both our Quality Assurance and Sales programs at Biotrofix. With McCormick LifeScience Consultants’ wide-range of services, efficient processes, and personal touch, we expect to continue this relationship long-term.
David Mantus, PhDPrincipal / C after D Inc.
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.
Laura MondanoVP / Regulatory and Quality
I can’t speak highly enough of working with Kelsey – she’s one of the most enthusiastic and effective professionals in the industry. Not only is she incredibly responsive, but she understands her disciplines very well and through that always delivers high-quality, results-driven work. She consistently brings top-notch consultants to the table and, most importantly, she can tailor her work to your specific project to make sure you get exactly what you need. She’s also very open to negotiation to assist those on a tight budget. I hope your experience with McCormick LifeScience is as positive as mine has been.
Duncan Whitney, SVPR&D & Technical Operations / Diagnostics company
Kelsey, President of McCormick LifeScience Consultants was instrumental in supporting our clinical trials by providing a critical medical specialist. She worked in a timely and efficient manner. She has also been helpful and understanding of our needs and requirements as our company has met challenges over the last couple of years.
Cheryl, Assoc. DirectorGlobal Drug Safety Research and Evaluation / Takeda Pharmaceuticals International Co.
I have worked with Kelsey and McCormick LifeScience Consultants for a number of years. Kelsey has extensive Regulatory experience and is a detail-oriented individual who takes the time to understand her client’s needs. Kelsey is very committed to meeting tight timelines and providing the right individual to complete the assignment. She is professional and always a pleasure to work with. I recommend using McCormick LifeScience Consultants to those who are lacking organizational infrastructure, or have that extra assignment that needs to get accomplished!