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.