BioRegenis PV
Drug safety software
Technological maturity
61%
TRL level
TRL 6
BRG-PV
- TRL 1
- TRL 2
- TRL 3
- TRL 4
- TRL 5
- TRL 6
- TRL 7
- TRL 8
- TRL 9
Software that covers pharmacovigilance by analysing the scientific literature and issuing the update documentation on adverse reactions.
The TRL scale
We do not use clinical trial phase nomenclature, which would be inappropriate for devices, software and cosmetic products. The TRL 1–9 scale describes technological maturity, from a basic principle observed to a system proven in a real operational environment.
- TRL 10–11%
- TRL 212–22%
- TRL 323–33%
- TRL 434–44%
- TRL 545–55%
- TRL 656–66%
- TRL 767–77%
- TRL 878–88%
- TRL 989–100%
- The TRL 1–9 scale measures the technological maturity of a programme: the percentage marks its position along that scale, not its distance from market entry. Programme status updated August 2026.
The problem. Pharmacovigilance imposes a continuous obligation: monitor the scientific literature, detect safety signals and produce, in the required form and time, the update documentation on adverse reactions. It is recurring work, heavy in regulatory content and in manual effort, where delay is in itself a non-compliance.
The BioRegenis solution. Software that covers pharmacovigilance through literature analysis and the resulting issue of the documents required for the continuous update of adverse reactions, cutting manual work and documentation lead time.
State of progress.
Software development — completed, 100%
Prototype — under validation, 90%
A demo of the software is available on request and subject to authorisation.
Next milestone. Completion of prototype validation and start of use in an operational environment with the first users.
Expected applications. Marketing authorisation holders, pharmaceutical companies and regulatory service organisations subject to pharmacovigilance obligations.
Intellectual property. Proprietary software.