Skin safety studies: Design, materials provisioning, oversight, report reviewing for skin irritation, sensitization, photoirritation, photosensitization studies (using third party contract research organizations (“CRO”s).
Preclinical proof of concept: Design, materials provisioning, oversight, report reviewing for in vivo proof of concept studies (using third party contract research organizations (“CRO”s).
API and excipient sourcing: Support for selection, review, auditing of contract manufacturing organization (“CMO”) operating under good manufacturing practices (“GMP”) of active pharmaceutical ingredient (“API”) supplier; support for excipient sourcing and specification (using partner third party contractors).
Scale up and GMP manufacturing: Program and methods transfer to partner contract manufacturing organization (“CMO”) equipped for scale up, container filling and labelling under good manufacturing practices (“GMP”).
IND compilation and submission: Compilation, drafting, electronic submission of investigational new drug application (“IND”) (using partner third party contract research organization (“CRO”)).
Component performed by select Tioga Research third-party partner, in whole or in party.
While Tioga Research has the skills and experience to progress a drug product program from concept through to IND filing, we are also often engaged to complete just one or more phases in the process.