Luina Bio has a strong track record in supporting clients through the biopharmaceutical manufacturing of clinical trial material and licensed products (for veterinary use). With this experience comes the expertise needed for regulatory documentation and other regulatory support centering on CMC development.

The Regulatory Support Process

A dedicated project manager, in conjunction with biopharmaceutical development, manufacturing, testing, and quality subject matter experts, will review your project and assure the proper verification of product quality and assembly of regulatory documentation for your regulatory filing dossier. We assist in the development of Quality Target Product Profile (QTPP) and post Phase 1 CMC submissions and will continue to provide CMC data to support clinical studies or develop data for future NDA submissions.

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If you’re using Quality by Design (QbD), we 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 and supports a planned marketing application.

Over the years, Luina Bio has successfully supported its clients in numerous 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 regulatory challenges faced on the path to market introduction. When you need specialized regulatory advice, Luina Bio works with our partners to ensure you receive brilliant service.