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
With almost 30 years of regulatory experience, Obelis Group can safeguard your products’ 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.