Obelis Scientific Department Officially Launched!
On 1st September 2016, Obelis officially launched a new department within the company structure – 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 – Obelis Chief Compliance Officer.
Scientific Department services include, but are not limited to, the following:
- Borderline Classification
- Notified Body Selection
- Notification of Clinical Investigations
- Technical File (Creation/Review)
- Identification of Harmonized Standards
- Clinical Evaluation Report
- Risk Management Report
- Vigilance & Incident Reporting (FSN & FSCA)
- Trade Mark Submissions
- Training & On-site visits
- Horizon 2020
If you need any support in reference to the above-listed services, do not hesitate to contact us.