Drug Product Formulation & CMC Consulting

Expert consultation on drug product formulation and process development for small molecules: from concept to patient

Are you looking for a reliable consultant to help your team advance the development of your drug
formulation and process, from small scale concepts all the way through NDA approval? KM Consulting
brings decades of outstanding experience to help sponsors navigate the challenges of drug product
formulation and process development of small molecules.

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What we do
Expertise in Drug Product Formulation

KM Consulting-Pharma Intelligence LLC resulted from a vision of a veteran in the field of Drug Product
Formulation and Process Development. Our founder brings over 20 years of experience helping
Innovators, Generic Pharma and CDMOs successfully deliver their drug product programs.

We offer specialized support in pharmaceutical development and Drug Product Formulation. Additionally, you can check out our full range of services to learn more. Therefore, partner with KM Consulting to ensure your project’s success.

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

Drug Product Formulation and Process Development (small molecules): we help advance your formulation from pre-clinical phases until late-stage clinical phases and commercialization approval. 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

Founder and Principal Consultant

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.