Regulatory compliance is absolutely key to your success in both the EU and UK markets. As we all know, regulation is weighing down on manufacturers it is becoming costly and burdensome to handle in-house. Particularly since the EU has raised the standards for compliance with the introduction of Regulations (EU) 2017/745 & 2017/746. However, there is some good news and light at the end of the tunnel, Advena can ease the drain on your internal resources by providing cost-effective solutions.
Our team of professionals offers a range of services to meet your regulatory needs for both the EU and UK market. Here is a small selection of services available.
- Technical Documentation Compilation.
- Gap Analysis / File Reviews.
- Clinical Evaluation Plans & Reports (CER & CEP).
- Performance Evaluation Plans & Reports (PEP & PER).
- Risk Management File.
- Device Classification.
- General Consulting.
If you are interested in any of the above services, please do contact us, we can begin with a conference call over Teams or Zoom to introduce you to members of the team and discuss your regulatory needs. Following on from that, we will provide a detailed quotation for your review.
At the completion of a project, a package of documents will be provided for your review. These documents are yours to keep and maintain. However, as always, we remain on hand should you require any amendments or need to make additions.
As many of you are aware, within the office here in Malta we have an excellent team of regulatory consultants. Therefore, if this is an area of expertise or of resources that you do not have at your disposal or your internal resources are stretched, please remember we can provide you with a cost-effective solution.
Contact us today to arrange an appointment: info@advena.mt
