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Safe Devices for Drug Products

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Medical devices intended for delivering medicinal products can impact the quality, safety, and efficacy profile of said medicinal products. The EU requires additional information for devices that are co-packaged or cross-labelled as intended for drug delivery.

SAXOCON provides you with everything you need to test and document compatibility with the drug product in compliance with regulatory requirements, including:

  • The selection, screening, and characterisation of delivery device construction materials
  • Selecting appropriate laboratories, reviewing protocols, and monitoring extractable and leachable studies
  • A toxicological risk assessment of the results

Why choose us?

SAXOCON services for the development of drug-device products give you access to:

  • Extensive, best-in-class experience with the development of drug-device products in accordance with the complex landscape of international standards and regulatory guidelines
  • A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
  • Safety evaluations based on proprietary information obtained from our worldwide network of materials suppliers
  • Smart, cost-effective test strategies that bring your products to market in a timely manner

Delivery

SAXOCON compiles all additional documentation necessary for developing a new Drug Application file in accordance with EMA requirements.

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