Although based in Southampton, UK, MB Consult provides an international service. Currently about half our work is in the USA. Close contact with the US and European Regulatory Authorities ensures that we not only understand the current issues - we also know the people.
We have an enviable track record particularly within the veterinary pharmaceutical and animal feed industries and are closely involved with those microbiological issues high on the agenda of CVMP and CVM. We are closely involved with the antimicrobial resistance and efficacy issues addressed by CVMP Guidelines 644 and 627 as well as FDA Guidance #152. Additionally we have had a direct involvement in finalising the microbiological ADI harmonised guideline VICH 36, which in Europe is CVMP/VICH/467/03- FINAL and in the US is FDA Guidance #159. Significant experience in risk analysis as it relates to public health issues arising from the use of antimicrobial compounds.
- Provision of Expert Microbiology Advice
- Advice on Progressing R&D programmes to Meet Regulatory Requirements
- Independent Assessment of Microbiology Issues & Reports
- Assessing & Reviewing Data and Dossiers
- Microbiological Dossier Preparation
- Preparation of Expert Reports with specific regard to CVMP Guideline CVMP/VICH/467/03-FINAL and FDA Guidance for Industry #159 - Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
- CVMP Guideline CVMP/VICH/644/01-FINAL - Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
- CVMP Guideline EMEA/CVMP/276/99-FINAL - Note for guidance for the assessment of the effect of antimicrobial substances on dairy starter cultures
- CVMP Guideline EMEA/CVMP/627/01-FINAL 627 - Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances
- Animal Feed Expert Reports with regard to relevant EFSA regulation
- Microbiological Risk Assessment
- Microbiological Trouble Shooting
- Assessment of New Technologies & Opportunities in Microbiology and Biotechnology
- Microbiology Literature Awareness Services
- Quality Systems and Laboratory Accreditation Programmes
- Expert Witness and Court Representation
- Project Management Services
- Experimental design
- Placing studies in appropriate centres
- Monitoring and reporting studies
- Co-ordination of multi-centre studies, nationally and internationally
- Technical Writing
- Marketing Support
