Pediatrics
Eurofins CDMO network of companies offers customized drug development to meet your young patient needs
Medicines are not always available in a pharmaceutical dosage form suitable for children and then administrated as there is no alternative. The use of adult medicines on children (by crushing tablets or by manufacturing extemporaneous formulations) increases the risk of inefficacy and/or adverse reactions and impacts negatively the compliance.
In this context, pediatrics drugs have become a public health priority to answer unmet medical needs. Following EU and US regulations, Pediatrics Investigation Plans are requested as a research program to ensure that the necessary data are generated determining the conditions in which a medicinal product may be authorized to treat the pediatric population.
As a very experienced CDMO with fully scalable GMP manufacturing facilities, Eurofins CDMO network of companies is ideally suited for the development of your pediatric medicinal products:
- More than 25 pediatric clinical batches developed & produced
- Several pediatric medicinal products manufactured for clinical and commercial use in EU markets
- Customized development and manufacturing for pediatric products such as ODT, solution, suspension, oral gel, granules, multi-particulate formulations (e.g. mini-tablets, coated beads…)
- Pre-formulation and characterization of pediatric drug substances and drug products
- Taste masking (flavoring, coating…)
- Primary packaging adapted to pediatric products (sachets, blisters, bottles, child resistant packaging, dosing devices…)
- R&D and ICH stability studies, both long term and accelerated, including ASAP studies
- Regulatory CMC support
- From clinical drug product development to commercial production with facilities for small batch sizes
