Pharmaceutical Products

In accordance with Good Laboratory Practice, in the pharmaceutical industry Renolab is able to perform:

• physical and chemical tests on both active substances and formulated products
• stability tests
• studies to identify organic and inorganic impurities in pharmaceutical products and medical device
• development and validation of analysis methods for the determination of drug residues in various matrices

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.

Regulatory framework

• 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.

 

Veterinary products

With regard to veterinary products, the laboratory performs:

• physical and chemical tests on both active substances and formulated products
• stability tests
• studies to identify organic and inorganic impurities in veterinary products
• development and validation of analysis methods for the determination of veterinary drug residues in various matrices

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.

Regulatory framework

• Commission Directive 2009/9/EC of 10 February 2009 amends Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use.