EG-200Work
Work
My work sits where regulatory, manufacturing and commercial decisions meet: the part of pharmaceuticals between a medicine existing and a patient being able to get it.
Emona Biopharma
Emona Biopharma is a GMP-licensed pharmaceutical company in Slovenia, working on the licensing, importation, testing and release of medicines for European markets.
A large part of my work is evaluating products, finding partners, getting medicines registered, solving problems during tech transfer and manufacturing, and eventually getting them onto the market. In practice that means a lot of the job is the joins: the moments where a regulatory question turns out to be a manufacturing question, which turns out to be a commercial one.
| Step | RegulatoryReg. | ManufacturingMfg. | CommercialComm. |
|---|---|---|---|
| 01 Evaluate the product | |||
| 02 Find partners | |||
| 03 Register | |||
| 04 Tech transfer & manufacturing | |||
| 05 Import, test, release | |||
| 06 Bring to market |
Pramit
I also sit on the management board of Pramit, our GDP-licensed pharmaceutical distribution business. It has been supplying medicines across Central and Eastern Europe for more than 20 years, which in this industry makes it an institution.
Earlier
- Before Emona
- Pharmaceutical business development, selling crowdfunding projects, selling very expensive vacuum cleaners, among other things.
- Education
- University of Amsterdam
Useful for
- Business development & partner search
- Regulatory affairs & registrations
- In- and out-licensing
- EU market entry for non-EU manufacturers
- Tech transfer & manufacturing problems
- GMP / GDP operations
- Commercial operations