A thorough knowledge of the working methodology for sterile injectables is not easily acquired, but herein lies our strength as managers of laboratories that manufacture Class III Medical Devices.
Management of global design projects, start-up of facilities, and process improvement for the manufacture of Class III Injectable Medical Devices, and the manufacture of mono- and multi-dose eye drops in accordance with European directive 93/42/EC.
We are specialised in projects and facilities for the manufacture of hyaluronic acid-based products used in orthopaedics, rehabilitation, ophthalmology, dentistry and aesthetic medicine.
We can advise you on the manufacture of ampoules, vials and prefilled syringes in accordance with ISO standard 13485.
We adapt the laboratory’s working methodology to the GMPs.
We help you obtain CE marking, handle applications to the healthcare agency and prepare dossiers for the notified body.
Our contacts with laboratories in the industry allow us to offer you the outsourcing of manufacturing to third parties, contract manufacturing, and contract filling.
In short, Intropharma can manage a turnkey project for you, from product innovation to manufacturing and final placement on the market. You decide which stages of the process you need.