Leap 3.8.5 – Comprehensive file management application. Version 3.8.5: Yep and Leap both drag files out better, especially to Terminal, etc. Note 2 to entry: Performance can relate to the management (3.3.3) of activities (3.3.11), processes (3.4.1), products (3.7.6), services (3.7.7), systems (3.5.1) or organizations (3.2.1). Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO. Leap 3.8.5 – Comprehensive file management application. K'ed Leap Productivity. Leap shows you all your files and more importantly – where they are on your computer. No other tool does this. Works great for images and PDF’s, too. Leap does not force you to put documents in a special place, it uses no databases. Just see whats on your. LEAP makes law office practice and management fun. LEAP's team of professionals like Amy Marinho and Terrance Morgan are just a phone call or an email away. They are always there to help you, by making training on LEAP fun and easy. They quickly responding to any questions you may have in regard to LEAP.
This guidance document gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and Regulations.
Who this guide is for
Leap 3 5 2 – Comprehensive File Management Application Pdf
Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use
In this guide
1. Introduction
5. Classification of a therapeutic product
6. Specific submission/application pathways
7. Guidance for implementation
7.1 Pre-Submission or pre-application meetings
8. Filing of information to Health Canada
9. Submission/application processing
10. Screening of submissions/applications
10.1 Screening of a submission/application during the Screening 1 period
10.2 Solicited Information
10.2.3 Screening Deficiency Notice (SDN)
11. Scientific Review of submissions/applications
11.1 Scientific Review process
12. Solicited information during the Scientific Review
12.1 Solicited information
12.1.3 Notice of Deficiency (NOD) - NDS, SNDS, ANDS, SANDS or an Application for a DIN (DINA, DINB, DIND)
13. Completion of the Scientific Review of a submission/application
13.6 Notice of Non-Compliance (NON) - NDS, SNDS, ANDS, SANDS, or an Application for a DIN (DINA, DINB, DIND)
Leap 3 5 2 – Comprehensive File Management Application Form
Bureau of Policy, Science and International Programs Therapeutic Products Directorate Health Canada 1600 Scott Street Holland Cross, Tower B 2nd Floor, Address Locator 3102C1 Ottawa, Ontario K1A 0K9 Facsimile: 613-941-1812 E-mail: [email protected]