CTD Dossier & Expertise

With reference to the experience gained in regulatory support for customers, Lamp has gained the knowledge and skills needed to prepare core regulatory documents for the presentation of new medical specialties and medical devices.

In particular, we are able to prepare CTD 2, 3, 4 and 5 modules in their completeness and set up technical files for medical device devices designed and manufactured at our plant.

Studies, which allow us to create new innovative formulations, are supported by the competence of the quality control, R & D and AQ service.