What an OEM project covers
An OEM or private-label project usually concerns the presentation of a product rather than its formulation: carton artwork, label text, syringe or vial labelling, leaflet layout, and the documentation set that accompanies a shipment. Which of these can be adapted depends on the product, the destination market and the approved labelling for that market. We agree the adaptable elements in writing before any artwork is produced, and we do not describe a formulation change as a simple packaging option. If you need a different specification rather than different packaging, that is a separate technical discussion handled through the same enquiry channel.
Start with the specification
Before artwork, agree the product: the HA line and gel texture, fill volume (1 ml, 2 ml, 10 ml, 20 ml or 50 ml presentations), material class (HA, PLLA, CaHA or polynucleotide booster), and box contents. Each line has its own specification sheet and Instructions for Use. Request the sheet for the exact presentation you intend to carry and put it into your purchasing specification. Comparing products by a single number, or copying wording from another brand catalogue, creates errors that are expensive to fix after labels are printed.
Documentation and regulatory scope
For every line we can provide the current specification sheet, Instructions for Use, labelling artwork references and certificate copies. Our CE and ISO 13485 documentation is issued by domestic certification bodies and is available on request. We do not present it as an EU-notified-body certificate, nor as automatically recognised in every market. Recognition, product registration and permitted use vary by country, so your own regulatory adviser should review the documentation pack before you commit to an order or to private-label artwork.
Packaging, traceability and supply information
Ask how lot numbers and expiry dates appear on both primary and secondary packaging, what one carton contains, and what the stated storage and transport conditions are. These details are part of the technical file and should be consistent with the IFU. Commercial terms — minimum order unit, available presentations and lead time — are quoted per enquiry rather than published here, because they depend on the specification and the destination. We do not invent figures for a website.
How an enquiry works
Send your market, the lines you are considering and whether you need standard packaging or a private-label project. We return the specification sheets, the current documentation pack and the commercial terms that apply to your case. If you are building a distribution business rather than your own brand, the distributor page describes that route. For a technical overview of how to read a data sheet, see our guide to hyaluronic acid specifications — but the individual product pages remain the source of truth for current specifications.
Specification-led
Every line has its own data sheet, IFU and packaging definition.
Documentation on request
Certificates, IFU and labelling references supplied with issuing body and scope stated.
Presentation range
HA lines, boosters and large-volume body presentations in one catalogue.
Enquiry-based
No published MOQ, price or lead-time figures — terms are quoted per project.
Define the product
Choose the line, volume and presentation; request its specification sheet.
Confirm the documents
Review the IFU, labelling and certificate set with your regulatory adviser.
Agree the artwork
Put the adaptable packaging elements and commercial terms in writing.
FAQ
Do you publish MOQ, prices or lead times? +
No. These depend on the specification and destination market and are quoted per enquiry.
Are the certificates issued by an EU notified body? +
No. Our CE and ISO 13485 documentation is issued by domestic certification bodies; recognition varies by country.
Can the formulation be changed for a private-label project? +
A specification change is a separate technical discussion, not a packaging option. Tell us what you need and we will confirm what is possible.
Can I buy products online? +
No. TOP-Q® is an inquiry-based wholesale and professional supplier with no online checkout or retail pricing.
Start an OEM enquiry
Tell us your market, the lines you need and whether you require private-label packaging.
Navigation
Supply and product information only. Not medical advice, a treatment recommendation or a substitute for the Instructions for Use. Product availability, permitted use and regulatory status vary by country.