Within the framework of Regulation No.528/2012, most of the studies have to be carried out in accordance with Good Laboratory Practice (GLP). This can be done internally if your company is GLP-certified and has the required techniques and equipment, but in most cases it has to be subcontracted to external laboratories (Contract Research Organisations, CROs).
Ambrosi Scientific Consulting (A.S.C.) offers comprehensive study management services including:
- Advice on the choice of the GLP laboratory
- Preliminary inspection of the laboratory
- Discussion with the laboratory regarding the study plan, related timeframe and cost
- In-depth review of the study protocol, its compliance with the relevant guidelines
- Close communication with the Study Director during the study period, to ensure that any issue is addressed immediately to avoid delays
- Conduct a study audit if necessary
- Audit of the draft report(s) to ensure that the final report is accurate, complete and in a correct format
Since 1999, A.S.C. has inspected and cooperated with many international CROs. The company has monitored more than 1 000 GLP studies, in the fields of physico-chemistry, mammalian toxicology, environmental fate, ecotoxicology, residues, etc.
In addition to GLP studies, A.S.C. offers to supervise biocidal efficacy trials.