The Fixed price IND package includes formulation development, product supply and preclinical studies typically needed for a first-in-human clinical trial in Europe.
All projects will be led by a dedicated project manager at Cadila to ensure seamless program execution.
The base package assumes an oral product, and that primary pharmacology, panel screening, placebo and API (synthesis and characterisation) is provided by the customer. It is also possible to have these parts quoted separately, and to tailor the program also in other aspects for your specific needs.
The fixed price of the complete standard package is 900 000 USD.
The pre-clinical studies of the program include the activities normally required by European authorities for a first-in-man (FIM) clinical study of an oral product. The experimental scope is subject to certain limitations – please contact us for further details.
CMC activities included in the package are formulation development and supply of drug product for first clinical trial, including release for clinical trial in Europe.
In addition to individual reports from all activities, deliverables of the complete package also includes IMPD writing for data from work performed by Cadila as part of the package.
See list below for all studies and activities included in the package.