Regulatory Affairs Support
LuinaBio has a strong track record in supporting clients through the manufacture of clinical trial material and licensed products (for veterinary use). With this experience comes the expertise to be able to offer our clients support in their regulatory filings with respect to the CMC sections.
A dedicated project manager, in conjunction with subject matter experts across the development, manufacturing, testing and quality review of your project, will assure the proper identification, quality, purity and strength for your regulatory filing dossier. Our Regulatory Affairs division will assist in the development of your Quality Target Product Profile (QTPP) and in post phase 1 CMC submissions will continue to provide CMC data to support clinical studies or develop data for future NDA submissions.
If you’re using Quality by Design (QbD) we can help facilitate pre-NDA discussions on format and details of a QbD containing submission. CMC discussion is particularly important during EOP2 meetings to evaluate CMC plans and protocols to ensure the data generated is meaningful to support a planned marketing application.
Over the years, LuinaBio has successfully supported its clients in a number of INDs, IMPDs, DMFs, MAAs and BLAs. Our experience in all aspects of CMC and regulatory dossier development will provide guidance and support over the myriad of regulatory challenges faced on the path to market introduction.