Services
Centaurus Consulting Group supports the Pharmaceutical/Biotech industry by providing services in CMC, Regulatory, Quality, Project and Process Management to development and approved products.
Whether you need help with a change to an approved product such as a tech transfer to a new manufacturer, facing a new NDA/BLA/MAA filing, review of historical documents or specifications and manufacturing/analytical procedures or you are just contemplating a complex project such as the opening of a new facility, we are here to help.
- Manage and execute Tech Transfer (manufacturing and/or testing)
- Manage and execute Validation (strategy, protocol, report)
- Review of Historical Source Documents to support an NDA/BLA
- Review of existing specifications, manufacturing processes and analytical procedures vs. approved dossiers
- Support with Technical documents
- Support with implementation of QbD
- Draft and review of CTD Sections (Modules 2.3.S, 3.2.S, 3.2.P, 3.2.A and 3.2.R)
- INDs/IMPDs and amendments
- Marketing Application (NDAs, BLAs, MAAs) and variations (prior-approval submissions, notifications)
- DMFs/ASMFs
- Briefing Books
- Meeting with Health Agencies (Preparation, meeting minutes).
- Preparation of Pre-Approval Inspections
- Audit of CMOs/CROs
- Review of deviations/CAPA
- Full Dossier management (NDA, BLA, MAA…)
- Product management
- Management of other complex enterprise-wide projects (such as regulatory or quality databases or project management applications)