On 1st September 2016, Obelis officially launched a new department within the company structure â€“ the Scientific Department.
Online PR News – 08-November-2016 – Brussels – On 1st September 2016, Obelis officially launched a new department within the company structure â€“ the Scientific Department. It makes up part of the Compliancy Unit and complements the pre-existing Regulatory Affairs & Quality Assurance Department.
The new department, which has already become fully operational, consists of a group of technical experts (chemists, pharmacists, lawyers) specializing in vigilance & incident reporting, technical documentation and safety analysis. The team is led by Mrs. Sandra FERRETTI â€“ Obelis Chief Compliance Officer.
Scientific Department services include, but are not limited to, the following:
â€¢ Borderline Classification
â€¢ Notified Body Selection
â€¢ Notification of Clinical Investigations
â€¢ Technical File (Creation/Review)
â€¢ Identification of Harmonized Standards
â€¢ Clinical Evaluation Report
â€¢ Risk Management Report
â€¢ Vigilance & Incident Reporting (FSN & FSCA)
â€¢ Trade Mark Submissions
â€¢ Training & On-site visits
â€¢ Horizon 2020
With almost 30 years of regulatory experience, Obelis Group can safeguard your productsâ€™ compliance and launch them successfully in the European market.
If you need any support in reference to the above-listed services, do not hesitate to contact us.