Solving CMC challenges shifts the risk profile favorably.
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 non-clinical studies and first-in-man studies. Comparability of the non-clinical 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.
Venn 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, Venn is the right place to advice you on your CMC strategy. We help you to strike the right balance between investing time in further characterisation and pharmaceutical development of your product and timing of non-clinical and clinical studies. Our services range from writing your pharmaceutical development plans to co-ordination of your clinical trial material using our network of contract service organisations and solving your analytical and manufacturing issues, using our brains and our hands-on experience.
- Pharmaceutical Consulting
- CMC Regulatory Affairs
- CMO /CRO Selection and Management
- CMC Project Management
- Investigational Medicinal Product Management