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Pharma Tech Outlook | Tuesday, February 02, 2021
The collaboration also offers consumers the ability to access additional unique facilities, which are not available anywhere else.
FREMONT, CA: QUNIQUE and Evnia recently announced their joint alliance for creative solutions. The two firms partner closely to further support their clients in regulatory relations, quality control, and pre-clinical/clinical reporting, with an in-depth focus on the current EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). The collaboration also offers consumers the ability to access additional unique facilities, which are not available anywhere else.
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Featured in Pharma Tech Outlook’s “Top 10 Compliance Services Companies in Europe -2020”, Evnia is a specialist consultancy firm that prepares the manufacturer’s compliant clinical assessment reports, technical documentation, and IVDR performance evaluation reports. “We at Evnia are very excited about this partnership,” said Dr. Efstathios Vassiliadis, CEO, Evnia. “Both of our companies understand that the IVDR and MDR compliance can only be achieved through a holistic approach towards quality management systems and pre-clinical and clinical documentation requirements. It is exactly this focus that makes this strategic partnership unique and provides unparalleled value to manufacturers.”
Joining Forces to Offer the Right Answers
As the due dates for MDR and IVDR applications are approaching, a growing number of business practitioners are requesting assistance from subject matter specialists to ensure that they meet the impending regulatory expectations. As far as certification is concerned, producers need to select the right advisory partner to direct them through a complicated documentation process. This was the starting point for the partnership between QUNIQUE and Evnia to innovate the market by combining experience in these fields and engaging specialists from diverse perspectives to offer the right solutions for mutual customers.
This cooperation would provide clients with access to a wide variety of resources, such as assistance with:
● Quality management systems;
● Pre-clinical and clinical documentation (CER) requisites of the MDR;
● Performance evaluation criteria of the IVDR;
● Sufficient training and industry events.
These exclusive offerings would provide producers with a strategic edge by keeping them best updated in the area of quality control and regulatory affairs.
Regulatory Strategy Premium Service
“An important aspect of this strategic partnership is that we will be able to offer an additional joined service to manufacturers,” said Dr. Bassil Akra, CEO, QUNIQUE. “Within this premium service, the Technical documentation including either the Clinical Evaluation or Performance Evaluation Reports, prepared by Evnia, will be reviewed independently by us at QUNIQUE, weighing in regulatory and notified body experience in the content and output. This premium service will reduce the risk of manufacturers by getting pre-challenged documentation before submission.”
With considerable expertise in producing clinical and technical documents, Evnia is now focused on conducting clinical investigations and clinical trials to make data that can validate its evaluation process. “We are committed to creating the necessary data and evidence to ensure that the circle of trust is always complete so that the patients can always receive better quality of care,” adds Dr. Vassiliadis.
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