KM Consulting

Expert CMC guidance tailored to your program needs, from concept to patient

Are you looking for strategic support to advance the development of your drug candidate? KM Consulting is here to help you navigate through the complexities of CMC Drug Product Development.

What we do
Excellence in Biotechnology Consulting

KM Consulting-Pharma Intelligence LLC resulted from a vision of a veteran in the field of biotechnology. Our founder has more than 20 years of experience helping Innovators, Generic Pharma and CDMOs successfully advance the development of their drug product.

KM Consulting – Pharma Intelligence offers deep expertise in two main areas:

Formulation and Process Development (small molecules): we help advance your formulation from late discovery and pre-clinical phases until late clinical phases and post commercialization. Serious scientific support, blending art and science with a phase appropriate approach.
CDMO selection: we can provide strategic guidance on the selection of your contract development and manufacturing partner, based on the needs of the program.

About Us
Meet our expert

At KM Consulting, our strength lies in the knowledge and experience of our founder Michelle Gischewski

Michelle is a pharmacist with over 20 years of experience, educated in Brazil and Canada.

Her career has been dedicated to mastering the challenges and nuances of formulation and process development, from strategic proof-of-concept projects in the late discovery phase, through scale-up and optimization in clinical trials, and continuous improvement post-commercialization.

Michelle successfully led scientific teams in large organizations such as Eurofins CDMO, Apotex and Teva; helping clients navigate the complexities of drug product development. She is highly recognized for blending science rigor with practical approaches.

Differentials
What makes us unique…

Proven Experience:

More than 20 years of experience in successfully running programs from start to finish.

Scientific and Pragmatic Approach:

Our strategy combines scientific rigor with practical solutions, tailored to the specific needs of the client and phase of the program.

Customized Solutions:

We understand that each program is unique. We offer expertise to help guide clients as they navigate programs from concept to the patient.

Expert CMC guidance tailored to your program needs, from concept to patient

What we doExcellence in Biotechnology Consulting

About UsMeet our expert