BradyKnows provides full regulatory services to this world’s innovative cancer care solution manufacturer, covering the regulatory strategy, import customs clearance, onsite type testing, dossier preparation, initial registration, modification, renewal etc.
| Brady Service Description | Duration | Brady Resource | Note |
| Regulatory and Clinical Strategy for full product pipelines | 0.5 month for each product | VP of Clinical and Medical Affairs * 1 Clinical Director * 1 Technical Director * 1 Regulatory Director *1 | • For each product, BradyKnows team will make assessment and provide the regulatory and the least burdensome clinical solution. • e.g. how to balance certificate renewal and modification; if modification is required for software upgrade |
| Registration for initial overseas product | 18 month for linear accelerator | Technical Director * 1 Onsite test engineer * 1 Regulatory Director *1 Sr. RA * 2 PM * 1 | • Prepare checklist of registration for tracking project schedule • Prepare type testing dossiers, including Product Technical Requirement (PTR) • Coordinate sample import and delivery • Select appropriate test center • Onsite support testing • Prepare registration dossiers • Train and help on software description document, cybersecurity document and service life document as per China unique requirement • Do E-filing for registration dossier submission • Communicate with NMPA on queries • Confirm certificate information |
| Registration for initial domestic product | 14 months for linear accelerator | Technical Director * 1 Onsite test engineer * 1 Regulatory Director *1 Sr. RA * 2 PM * 1 | • Prepare checklist of registration for tracking project schedule • Prepare type testing dossiers, including Product Technical Requirement (PTR) • Coordinate sample delivery • Select appropriate test center • Onsite support testing • Prepare registration dossiers • Train and help on software description document, cybersecurity document and service life document as per China unique requirement • Do E-filing for registration dossier submission • Communicate with NMPA on queries • Confirm certificate information |
| Certificate modification for software upgrade | 12 months for software upgrade | Technical Director * 1 Onsite test engineer * 1 Regulatory Director *1 Sr. RA * 2 PM * 1 | • Prepare checklist of registration for tracking project schedule • Prepare type testing dossiers, including Product Technical Requirement (PTR) • Coordinate sample delivery • Select appropriate test center • Onsite support testing • Prepare registration dossiers • Train and help on software description document, cybersecurity document and service life document as per China unique requirement • Do E-filing for registration dossier submission • Communicate with NMPA on queries • Confirm certificate information |
| Certificate modification for manufacturing site change | 4 months for manufacturing site change | Regulatory Director *1 Sr. RA * 1 PM * 1 | • Prepare checklist of manufacturing site change for tracking project schedule • Prepare manufacturing site change documents (e.g. risk management report) • Do E-filing for dossier submission • Communicate with NMPA on queries • Confirm certificate information |
| Certificate modification for legal agent change | 1 month for legal agent change | Regulatory Director *1 Sr. RA * 1 PM * 1 | • For all 18 certificates of this client to change legal agent • Prepare checklist of legal agent change for tracking project schedule • Prepare documents for legal agent change • Do E-filing for dossier submission • Communicate with NMPA on queries • Confirm certificate information |
| Certificate renewal | 2 months for certificate renewal | Regulatory Director *1 Sr. RA * 1 PM * 1 | • Map out strategy to do certificate renewal first or do modification first • Prepare checklist of certificate renewal for tracking project schedule • Prepare documents for renewal • Do E-filing for dossier submission • Communicate with NMPA on queries • Confirm certificate information |
| Import customs clearance consultation | 0.5 month | Regulatory Director * 1 QA Director * 1 Sr. RA * 1 | For the import of products for testing, provide consultations on the import process, model selection strategy for import, the customs clearance statement from test center etc. |
