Small Molecule Development
Syngene offers comprehensive end-to-end development (CMC and pharm tox) services to advance the clinical candidates selected for pre-clinical and clinical development. The CMC services include process research and development, cGMP supplies, formulation development including clinical supplies, Analytical R&D including stability studies and the pharm tox services include regulatory toxicology and safety pharmacology studies required for an IND filing.
Integrated development programs are managed by development co-ordination team which comprises a process chemist, analyst, formulator, toxicologist, and representatives from the discovery group, if Syngene has been involved in the discovery stage of this program. This team with support from a project manager tracks the overall progress of the project in close co-ordination with the participation of the client’s scientific team. The ability to have this multi-disciplinary team and the availability of the infrastructure required to offer these development services ensure Syngene is able to execute the overall project in a very efficient and cost effective manner minimizing the overall time required to complete the development phase of the program.