Aurena Laboratories OEM private label products

Private label, also known as ‘own label’ or ‘store brand’ products, continue to gain in popularity with consumers. This has long been the case with FMCG fast moving consumer goods but is also now the case for pharma and medical products as well.

In part this is driven by price and economic necessity but is also a function of increased confidence that own brand products will be produced to the same quality and regulatory standards as branded ones from the big players.

Aurena private label offer

Aurena Laboratories has long been a part of this trend, with an impressive track record of acting as a private label pharmaceutical company, offering a white label range of innovative medical device classified spray products that are CE-marked as registered and approved and also MDR compliant.

Aurena Labs provide a fast track and low barrier route for any new entrant to healthcare markets to sell registered and approved private label products under its own brand name. Aurena will act as both registered producer and Original Equipment Manufacturer (OEM), producing a white label product to which customer branding can be added. Aurena can also provide the design and labelling services required.

CE-Marking and Regulatory compliance

Achieving mandatory CE compliance for own brand medical products to be marketed within the European Union can be a complex process because of the requirements of individual directives – and particularly when combinations of directives apply simultaneously.

All of Aurena’s white label saline-based spray products, incorporating advanced and environmentally friendly Bag on Valve (BoV) technology, have been certified by Notified Body and Competent Authority so that they can carry CE marking as testament of efficacy, quality and safety, backed by third-party laboratory testing and documented evidence for scientific and therapeutic claims.

The client will source the own label product under a distribution agreement from Aurena, who accepts all responsibilities for product quality. A distributor whose name appears on the own brand product will not be considered as manufacturer if it is sold under Aurena’s name as actual OEM manufacturer.

Private Label Manufacturer Process

The private label manufacturing offer allows clients to source products direct from Aurena, who has already undertaken regulatory certification and act as Notified Body for OEM manufacturer responsibilities or liabilities.

Once the design of the new label with the new brand name is finalized Aurena will add the new version to the master file of the original products, ensuring it retains compliance will all requirements.

The new brand version of the product will be included in the ongoing regulatory work with Notified Bodies and Competent Authorities.

A new label, including the customer brand name will be designed. Aurena will add this artwork to the existing product list and technical file for the already CE-marked product.

OEM own-label advantages

Using Aurena Laboratories as OEM for own-branded products delivers a series of key client benefits. These include:

• Verification and assurance that the product conforms with all brand claims
• Development of new artwork, and if needed, language translation
• Distribution agreement between Aurena and distributor, including commercial conditions
• Full traceability vigilance, product change control and post market surveillance

Resources

Click on Aurena Private Label Products for more information.