Tioga Research frequently collaborates with select third-party vendors during the formulation development process. 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.
Some of the studies that Tioga Research collaborates or helps oversee are listed below:
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
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