what's possible with aurena | aurena labs

What’s Possible with Aurena

From  product  development  to  packaging  and  

cer3fica3on,  your  product  deserves  the  a9en3on  of  a  leader  in  medical  device  and  

bag-­‐on-­‐valve  (BOV)  packaging.    

Partner with Aurena for innovative and creative solutions to your contract

development and manufacturing needs

We collaborate with you to make the following possible…..

Range of Approved Medical Device Products

Private Label •  Aurena will act as the legal

manufacturer and OEM.

•  The product will say “Manufactured by Aurena”, but will have the client’s brand name and graphic design.

Own Brand •  The client places the product on

the market and has the full product responsibility. The CE-product registration will coincide with Aurena’s.

•  The product will say “Manufactured by <the OBL company>

Visit aurenalabs.com for more information

Market an Aurena OEM product under your brand name, with one of these two options:

Product Development

•  Pre-formulation development and formulation development for liquids, gels or creams for bag-on-valve packaging

•  Unique expertise in saline based formulations, sprayable emollients, and wound and skin formulations using advanced silicone technologies

Small Scale Production

•  Flexible solutions to test your product’s stability and see it in bag-on-valve packaging: –  Make products based on as

little as 1 liter of your product bulk.

–  Perform small scale fillings if you only need a few hundred or a few thousand products.

CE-Marking and Regulatory Support

•  All medical devices sold in Europe must bear the CE mark to be legally sold. Aurena works with clients to support the regulatory process, including:

–  Device classification

–  Evaluation and substantiation of product claims

–  Preparation of the technical documentation and file

–  Audit and notification process

Logistics

•  Getting your product in markets around the world in a timely, safe and cost manner is critical to the success of your brand

•  Work with Aurena for a logistic solution that follows all necessary aerosol regulations

Licensing and Partnering

•  Work with Aurena to develop innovative medical device products through in-licensing of intellectual property and products

•  Aurena may also be interested to license your IP for commercialisation on other markets

Packaging Development and Graphic Design

•  Catch the attention of your consumer with high-quality graphics designed by Aurena on your BOV packaging:

–  Enhance the aluminum container with full body design or sleeves

–  Eliminate secondary packaging

–  Innovative self adhesive booklet labels

Sterilisation

•  Validate and perform the sterilisation of your products with a trusted partner that uses an effective sterilisation process:

–  Since gamma rays are able to penetrate aluminium, the most convenient sterilization method for BOV products is gamma irradiation.

–  Gamma irradiation is normally used for products that shall be classified as sterile.

–  The most common irradiation dose is a minimum of 25kGy, even if lower doses are also used. Minimum and maximum irradiation doses shall be validated for each product.

Let’s work together. For more information, visit aurenalabs.com