READY! is being used to track milestones and store documents created in the development of a new medicine.
All documents and information gathered and produced in the development phase can be tracked and accessed by the regulatory team in preparing regulatory strategy and planning applications for Marketing Authorisations.
The result is improved efficiency and faster access to the market.
Typical steps in the development of generic pharmaceutical medicine supported in READY!:
Development product definition
Reference Listed Drug (RLD) definition
Deformulation of RLD, feasibility study
API source selection
Finished dosage form development
Process optimisation study
Transfer to a manufacturing site
Regulatory strategy definition
The documents and records stored in READY! for each medicinal product include:
RLD definition, feasibility studies, pre-formulation study protocols and reports, composition, morphology, manufacturing info, QA status, agreements, IP assessments, pricing, analytical methods, validation reports, stability data, packaging info, regulatory status, various studies, master manufacturing documents, master packaging documents, process and cleaning qualification protocols, bioequivalence and other studies, bioanalytical reports, CRO info, stability info, shelf life development, shipping study, package development, packaging validation, validation protocol, batch records, analytical methods transfer, finished dosage form/package documentation strategy, clinical documentation strategy, and regulatory procedure strategy.