Do you grant exclusivity?
Yes, by territory and by product family, against an agreed annual volume and a registration
timeline. Terms are set case by case — bring your volume forecast.
What is the minimum order?
There is no fixed minimum per item — you can mix SKUs to reach a minimum order value, so
cements, clips and anchors travel in the same shipment. Your first market-seeding order is
treated separately: tell us what your surgeons need to evaluate and we will work to that,
not to a container.
Will you do OEM or private label?
Yes. We manufacture in our own plants, so your brand, your packaging and your carton artwork
are all on the table. This is a large share of our existing export business.
What registration documents come with it?
CE certificate, ISO 13485:2016, KGMP, Declaration of Conformity, Free Sale Certificate,
Certificate of Origin and IFUs. Summary technical documentation on request under NDA.
Legalisation supported where required.
What is the lead time?
4 – 5 weeks from order as standard. Cements and β-TCP are produced to
stock; anchor and instrument sets are built to order, which is where the upper end of that
range comes from.
Who supports us after the contract?
Product documentation, IFUs and direct contact with our regulatory team while you file.
Training, workshop and marketing support are agreed case by case — tell us what your team
needs and we will tell you what we can commit to before you sign, not after.