Pharmaceutical Development (CMC)

In early development, the major pharmaceutical development challenge is the design of drug product, drug product formulations and drug manufacturing methods of drug chemical or biological compounds that are suitable for an early start of nonclinical studies and first-in-man  studies. Comparability of the nonclinical drug substance and drug product and the clinical ones is key in that stage. In later stage the focus shifts to patient friendly and stable drug formulations, robust manufacturing and analytical methods of both drug substance and drug product, and cost of goods. 

Kinesis Chemistry, Manufacturing & Control (CMC) consultants have experience in both early and late development for small molecules, biologics, herbal medicinal and nutraceutical products. Whether you need a tablet, a cream or an injectable product, Kinesis is the right place to advice you on your CMC strategy. We help you to strike the right balance between investing time in further characterization and pharmaceutical development of your product and timing of nonclinical and clinical studies. Our services range from writing your pharmaceutical development plans to coordination of your clinical trial material using our network of contract service organizations and solving your analytical and manufacturing issues, using our brains and our hands-on experience.

 

"Solving CMC challenges shifts the risk profile favorably"

Contact details

Ron van 't Hof, Ph.D.
Director Chemistry, Manufacturing & Control
Tel: +31 76 5 480 638
Mob: +31 6 11 59 52 80
Email: ron.vanthof@kinesis-pharma.com
      

 

Consultants in drug development

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