Development

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!:

  • INN Selection
  • Development product definition
  • Reference Listed Drug (RLD) definition
  • Deformulation of RLD, feasibility study
  • Preformulation study
  • Feasibility study
  • API source selection
  • Finished dosage form development
  • Process optimisation study
  • Bioequivalence
  • Stability study
  • Packaging development
  • 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.