Are your production equipment and systems qualified for product contact?
On Wednesday 13 January 2021 from 15:00 – 16:30, we will be hosting a webinar on the role and design of extraction studies to ensure safety and quality in pharmaceutical manufacture.
- Welcome and introduction to presenters
- How to meet regulatory expectations for risk assessment of E&L in single-use systems – with Carsten Baun Senholt, Chief Technical Officer, SAXOCON A/S
- BioPhorum Operational Group E&L for single-use systems – The final chapter – with Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk
- Q & A from the chat window
As of today, 5 January 2021, all suppliers of physical products in the EU market are required to track and report the content of substances of very high concern (SVHC). This information shall be made available to consumers and waste operators by filling in the Substance of Concern in Products (SCIP) with the European Chemical Agency (ECHA). https://echa.europa.eu/scip
SAXOCON can help you comply with your obligations for tracking your supply chain, evaluating potential SVHC, and submitting your information to ECHA.
Do you manufacture an in vitro diagnostic medical device? If so, you will need a CE Mark certificate to market it in the EU. A CE certificate verifies that a product is safe and performs as intended. The regulation, (EU) 2017/746 (IVDR) Annex I, prescribes general safety and performance requirements for the design and verification of an in vitro diagnostic medical device product. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements and get your product to market.
The FDA is updating their current thinking regarding the type of biocompatibility information needed for certain devices made from common polymers and fabrics that are in contact with intact skin. Read more about the new FDA Guidance here.
SAXOCON can help you pick the right materials that will allow you to waive testing of certain medical device materials.
SAXOCON is ready for the EU MDR, are you?
26 May 2021 is the deadline for the full implementation of the new EU MDR (Medical Device Regulation). This will have far-reaching consequences for all medical device manufacturers that want to sell their products in the European Marketplace.
So, to continue marketing your products in the EU after this date, you will need to ensure that your products comply with these new regulations.
Are you ready? We are.
Check out how we can help get your products into compliance.
In order to market a medical device in the EU, a CE Mark certificate is needed. This certificate verifies that the product is safe and performs as intended. The ISO 18562-1 standard prescribes a process for testing and documenting the biological safety of the gas pathway of a medical device product intended to provide respiratory care or supply substances via the respiratory tract. SAXOCON can help get your products ready for approval.
SAXOCON now has the capacity to test and identify nanomaterials based on EC-definitions. Let us help you find out if the materials in your portfolio are, or contain, “nano” and to ensure that they meet all relevant regulatory requirements.
EFSA announced changes to the evaluation of food enzymes compiled in a joint dossier in March 2020. If you are part of a joint dossier on food enzymes you may need advice for your toxicological study strategy. SAXOCON’s highly skilled toxicologists can help you in planning, testing, and documenting the safety of your food enzymes.
Joint dossiers have led to several challenges and data gaps in submitted documentation, which is the background for EFSA requiring that enzyme applicants now send a company-specific full data package. Additionally, these requirements will also require a full toxicological package conducted in accordance with current regulatory guidelines.
For years it has been possible for food enzyme producers to group their individual food enzymes under one umbrella application, provided that these enzymes have the same catalytic activities, are manufactured substantially by the same process and originate from the same organism. However, due to confidentiality issues, this procedure has led to a lack of specific information on e.g. the production strain and the chemical composition of each food enzyme.
SAXOCON can help you quickly prepare for these regulative changes.
Today we held our first webinar via YouTube Live. Carsten B. Senholt, our Principal Toxicologist and CTO, discussed the breaking news about the newly released ISO/CD 10993-17. So, get up to speed on the newest requirements regarding conducting a toxicology risk assessment of medical device constituents.
SAXOCON A/S is proud to have hosted the first Extractables and Leachables (E&L) network meeting and we are looking forward to participating in this exciting and important network going forward.
The E&L network is conceived to support competence building and knowledge sharing among Danish pharmaceutical companies.
2019 has been quite a year for us here at SAXOCON. In July we became SAXOCON A/S and today we can proudly announce that we are a GAZELLE 2019 recipient.
This has only been possible thanks to our loyal customers and our skilled and dedicated SAXOCON employees. We take great pride in delivering high-quality and timely services that make a difference, ensuring that medical and medicinal products produced and sold around the world are biologically safe.