Our Research and Development unit can count on highly qualified staff supported by a consolidated partnership with the University of Modena.
We focuse our efforts on the “core technologies” of the company, where we have a strong “know-how” that comes from years of industrial experience.Among the main forms of development we count: powders, effervescent tablets, suppositories and ovules.
We can assist our customers in the following developmental milestones:
- Preformulation and degradation studies
- Formulation development
- Primary packaging definition
- Analytical method validation develoment & stability testing
- Clinical trial material manufacturing, control and release
- CTD dossier Support and expertise
Research and Development Services
Lamp San Prospero can offer a variety of R&D services:
- Chemical, pharmaceutical and microbiological analysis service (including stablity studies in accordance with ICH)
- Product and process validation (including stability studies and regulatory affairs)
- Process development (up to clinical trial scale)
- We’re specailist for providing CTD for different products in sachets
- Application for marketing authorization
- Development of design solutions for packaging and marketing
- Co-operation up to the printing stage
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.
