GDP distribution
Warehousing, pick, pack and dispatch, order receipt, bona fide checks and invoicing through our accredited distribution partner.
Regulatory approach
For a manufacturer, choosing a UK partner means trusting them with your product and your regulatory standing. We look at the UK regulatory route before we agree commercial terms, so that timelines and costs are realistic from the start.
- Marketing authorisation applications through the national route
- Change of ownership applications and MA transfers
- MA acquisitions from existing UK licence holders
- Regulatory due diligence and SmPC alignment
- Post-authorisation variations and renewals
- Engagement with the MHRA on behalf of partners
Quality and supply
We work through accredited specialist partners and expect clear documentation and traceability at every stage of supply.
Pharmacovigilance
Pharmacovigilance and medical information services managed by our specialist partner.
Responsible Person oversight
A qualified Responsible Person (RP/RPI) oversees regulatory affairs and compliance management.
Safety reporting
If you have a safety or quality concern about a product we supply, tell us as soon as you can.
Report an adverse event or quality concern
Email info@unifarma.uk and put “Adverse event” or “Quality concern” in the subject line.
Healthcare professionals and patients can also report suspected side effects directly to the MHRA through the Yellow Card scheme.
Responsibility
We publish our approach to ethical and responsible business in these documents.
Questions about our regulatory approach?
Tell us about your product and the regulatory route you have in mind.