Aenorasis Regulatory Affairs Department is the link between the company and the Regulatory authorities both in Greece and at an international level. It is of great importance for the company’s undisturbed operation because it guarantees the fulfillment of all provided guidelines.
The Regulatory Affairs Department is staffed with specialized scientists who have many years of experience and an excellent knowledge of their field. In addition:
- The department collects all necessary information and documents defined by the Greek and European legislation and, also, submits for approval the relevant files to the competent authorities in Greece and abroad
- It ensures compliance of the pharmaceutical products and medical devices with all applied laws, regulations and directives, during the whole period of the products’ marketing ( it also submits amendments, renewals etc.), while, on the same time, it contacts the competent authorities and the cooperating firms for the quick and undisturbed process of regulatory affairs
- It is responsible for configuring and producing the product’s packaging, the promotional/ accompanying material and the user’s manuals
- It is also responsible for price list issues in cooperation with the National Organization for Medicines and for the communication with the Ministry of Health and the Ministry of Development
Contact our Regulatory Affairs Department:
+30 210 6136332