As a member of the DTU family, we would like to congratulate the 19 participants in the 2022 Danish Tech Challenge, Denmark’s leading accelerator for hardware start-ups, at the DTU Science Park Futurebox incubator.
At SAXOCON, we specialise in in-silico toxicological testing, risk assessment, and regulatory documentation for pharmaceutical products and medical devices.
Our CCO, Lars Friis Mikkelsen, will attend the Medicon Valley Alliance event, THE FUTURE OF SWEDISH & DANISH LIFE SCIENCE, on Wednesday, 7 September 2022, in Lund, Sweden.
Feel free to get in touch with Lars if you want to know more about SAXOCON’s entire portfolio of toxicological testing, risk assessment, and regulatory documentation covering pharmaceutical products, medical devices, raw materials, food ingredients, and chemicals.
Exposure to aerosols can negatively affect health.
Using our SAXOCON Impactor tool, we can determine what is in the air at your workplace, if there are any risks, and how to mitigate potential problems.
We designed and built the SAXOCON Impactor to be a highly efficient, multi-stage impactor that collects airborne particles (down to the nanoscale) for analysis.
Our impactor is intended for on-site use and quickly collects the necessary samples. After collection, you return the impactor to us for an analysis of the collected particles to determine the distribution and concentration of sizes, whereafter our toxicologists establish their level of toxicity.
Gain some understanding about what is in the air you breathe and how it affects workplace safety.
Our CSO, Kirsten Inga Kling, has joined GAeF (Gesellschaft für Aerosolforschung e.V.) as a supporting member. We look forward to contributing to the discussion, learning, and sharing knowledge with other experts in aerosol research.
SAXOCON congratulates Arla Foods Ingredients on the positive EFSA opinion regarding their novel food application for Lacroprodan® BLG-100. We are proud that our contribution helped get the application over the finish line and look forward to Arla receiving full EU approval for BLG later this year.
If you are developing a novel food and need help to ensure compliance with EU and FDA requirements, check out how SAXOCON can help you here.
The EMA, FDA, and US EPA are looking to reduce unnecessary animal testing, which involves replacing in vivo animal studies with in vitro and in silico methods to determine the toxicity of a substance.
SAXOCON welcomes this focus on enhancing animal well-being while maintaining high standards for determining the safety of chemical compounds. These new methods are the future of toxicological risk assessment, a future that we have been at the forefront of for over 8 years.
Future-proof your development processes with our cutting-edge modelling and let our experts guide you to the best strategy for using New Approach Methodologies (NAMs).
We are on the verge to merge. Things in the regulatory space for medical device manufacturers are about to get easier.
In a new proposal on Quality System Regulation Amendments for Medical Devices, The FDA has decided to harmonize their GMP requirement for medical devices by incorporating the QMS requirements from ISO 13485.
This harmonization will ease the regulatory burden on medical device manufacturers selling on both sides of the Atlantic. Medical Device Manufacturers and their suppliers and subcontractors that are ISO 13485 certified will no longer have to comply with a different set of standards for approval in the USA.
SAXOCON is ISO 13485 certified and can help you with your QMS, which helps you comply with all relevant regulations but also gives you a better understanding of your supply chain and manufacturing processes.
Are you responsible for the production of pharmaceutical products such as vaccines? What if you suddenly find something unexpected, like some foreign material or particles in a batch of the vials you produce?
Sudden unexpected findings of particulate matter in or in contact with drug products are common in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management of product quality require identifying the root cause and evaluating the impact of such findings on product safety. This knowledge is crucial to deciding whether to release or recall affected product batches.
A quick response is necessary when a finding occurs. Your production is put on hold while identifying the affected lots, and then the hard work of figuring out the type and extent of the problem begins.
SAXOCON has the in-house expertise and experience to help you quickly assess, process, and help mitigate any unexpected findings.
Packaging is not the first thing we think of when we think of food. However, the biosafety of the materials used in food packaging impact the food contained within. So, it is essential to understand the health and safety consequences of the packaging. For more information, read this EFSA article on food contact materials regulations.
All food packaging materials, known as food contact materials, must be evaluated for their potential for transferring harmful substances to food. Every supplier in the supply chain for food contact materials is responsible for demonstrating compliance with all applicable rules and regulations regarding food contact materials.
SAXOCON can help you ensure that your materials comply with EU and FDA rules concerning food contact materials.
Do you manufacture in-vitro diagnostic medical devices?
If so, you will need a CE Mark certificate to market them in the EU. A CE certificate verifies the biosafety of your products and that they perform as intended. Regulations such as (EU) 2017/746 (IVDR) Annex I set general biosafety and performance requirements for designing and verifying in-vitro diagnostic medical devices. Our experts have the knowledge and experience to help you plan, test, and document compliance with all regulatory requirements and get your product to market.
To know your materials is the beginning of wisdom.
One key aspect of manufacturing is materials screening. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with your materials throughout your supply chain to help mitigate risk, reduce unexpected events, and keep regulators happy.
Manufacturers of medical devices, pharmaceuticals or combination products operating in the EU must ensure the quality and safety of the materials used in their products before marketing them. Early and robust materials selection helps meet regulatory requirements, mitigate risk, and get your products to market quickly.
Ensuring the biosafety of your medical implants is necessary for getting them in compliance with relevant regulations.
Medical implants come into intimate contact with the human body for periods lasting from a few hours to permanently. As such, they are subject to strict regulations regarding their safety. Manufacturers of medical implants need to apply for a CE Mark certificate if they are to be sold and used in the EU. A CE certificate verifies that a product is safe and performs as intended. The ISO 10993-1 standard describes the requirements for evaluating and testing the biological safety of all constituent materials in a medical device product.
SAXOCON has the expertise to help you get your implants compliant and certified for sale in the EU.