Pharmaceutical development takes a lot more than a promising drug candidate, and misunderstanding its requirement and pitfalls can lead to its premature failure. During the initial stage of pre-clinical development, a tremendous amount of resources are generally invested in the yield of the synthesis, with little attention towards its scalability or the control strategy. This is but one of the examples where setting a CMC strategy early on will avoid substantial waste of resources and time.
“An uncertain plan is still better than no plan at all”
Synmap Pharma is a small company who provides consultancy services to small and mid size-biotech in the field of pharmaceutical development: CMC, DS process development or project management. If you doubt your strategy, or would like to receive advice on the way forward, make sure to contact us.