Authorisation for the activity of Theradis Pharma as a Pharmaceutical Company was delivered by the French Agency of Sanitary Security of Health Products and registered under the N° MM07/178.
All operations involved in the management of Investigational Medicinal Products (IMP) are carried out under the responsibility and control of the Theradis Pharma Qualified Person (Pharmacist).
Manufacturing
- Secondary packaging of IMP : the studying of and carrying out of the secondary packaging
- IMP labelling : after secondary packaging or in order to extend expiry date
- Release of IMP batches by the Qualified Person (Pharmacist)
Management of Investigational Medicinal Products (IMP)
- Reception and storage of treatment from the manufacturer.
- Distribution of IMP: to investigation sites situated in France and throughout the world, the "follow up" of IMP, management of the acknowledgement of receipt at the moment of delivery and the expiry dates.
- Re-supply to the same sites if necessary and upon client request.
- Return of IMP at study end.
- Destruction of IMP or return to Sponsor at study end.
Regulatory Affairs
- Take responsibility for contact with health authorities.
- Requests for Import and Export licences.
Importation Operation
Aside from EEC countries (free exchange zone), the products imported by Theradis Pharma can also come from european countries outside the EEC and from other geographical zones.