For the production of registration dossiers, acting as principal investigator in association with other analysis centres, Renolab is able to perform residue studies in the context of toxicological studies, in accordance with the specific requirements and current guidelines.
Sectors of Application
- physical and chemical tests on both active substances and formulated products
- stability tests
- studies to identify organic and inorganic impurities in pharmaceutical and medicinal products
- development and validation of analysis methods for the determination of drug residues in various substances
- Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.