Notebook
This site is a collection of notes I’ve gathered over the years.
You’ll find everything from quick thoughts and diagrams to deeper dives into topics that caught my interest.
I made this space to keep track of what I’ve learned and to share it with anyone who might find it useful.
- Active Substance Master File (ASMF)
- Business Analysis
- Canada Submission Types
- Centralised Procedure
- Change Management
- Clinical Development
- CMC
- Common Technical Document (CTD)
- Data Exclusivity
- Drug Master File (DMF)
- Drug Therapy Process
- Enantiomers
- Line Extension
- Marketing a Drug Device Combination (DDC) Product
- Marketing Authorisation
- MDR
- MDR Classification Rules
- Medical Devices
- Mutual Recognition Process
- Non-Clinical Development
- Patterns in Business Analysis
- Product Development
- Project Management
- Regulations
- Regulatory Information Management
- Role of the Qualified Person (QP)
- Specific provisions applicable to homeopathic medicinal products
- Strategic Implications on the Choice of Route(s) Used to Obtain Generic Product Approvals
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