Biologics - Case Studies
Global Regulatory Data Development
Top Global Biologics and Biosimilars Developer
A top 8 global developer of Biologics and Biosimilars needed their internal regulatory data and requirements updated and confirmed for 45+ countries. The regions involved were North America, Asia-Pacific, Latin America, Middle East, and Intercontinental country listings. the request included categories for dossier format, submission requirements across the various Modules, GMP requirements, whether CPPs were required, important authorization procedures, whether local clinical trials were required, Agency Fees, translation requirements and who can submit/hold the license for biologics, pharmaceuticals, orphan drugs and pediatrics
RJR was able to access its' global network of regulatory experts to provide the requirements, where many had just changed over the last 3-4 months. The database was provided via an Excel spreadsheet. The information provided detailed each category request. In many cases, actual Agency regulation documents could be provided, when requested. Implementation dates for newly changed policies were also part of the information developed.
The spreadsheet provided allowed the client's global development and regulatory teams to work with the most updated information, which was paramount for coordination, data development and the development of project timelines which were achievable, but not unrealistically overly optimistic. This allowed the group's business partners to formulate credible business plans an forecasting to the investment community and other stakeholders. Updates were recommended every 6 months.