The Solution
GeneriQ, through its network of contacts in the Indian formulation space, reached out to developers experienced with filing products for the US market and experienced in the oncology space.
GeneriQ checked particular dossier availability and identified 2 developers who were working on generic versions of the particular drug. Developer at the more advanced stage of development (product had completed pilot BE) was identified.
GeneriQ conducted an independent review of the developer and the formulation and pilot BE results through its technical team and shared results with the client.
Term sheet was signed between client and developer with clear milestones and timelines identified for all activities leading to dossier completion.
GeneriQ kept a track of project completion and organized monthly reviews of project status and supervised a successful completion of the dossier. Subsequently, tech transfer activities from developers site to the CMO site in the USA was scheduled and completed successfully.
Result
Product successfully developed at formulators site and tech transfer successfully completed to clients chosen CMO.
