TMC Pharma Services can provide support in a range of subjects
To support you in developing, manufacturing and introducing successful products.
ConsultancyNon-clinical, manufacturing and quality
Non-clinical services
• Highly experienced non-clinical experts to review data for regulatory acceptability and advise on development strategy
• Location of, and liaison with, third-party toxicology providers
• Liaison with academic units to obtain pharmacodynamic data
• Well-established contacts with academic units for preclinical anti-infective products evaluation
Manufacturing and quality services
• Pragmatic and experienced specialist QPs (qualified persons) to
- provide EU QP certification for clinical trials, and
- review data for regulatory acceptability, compile IMPDs and advise on development strategy
- auditing of manufacturing sites for compliance with GMP
• Location of high-quality GMP units, particularly those able to produce special batch sizes
• Liaison with clinical trials supplies management units, importers and distributors
• Management of import and QP release of investigational and marketed drugs in the EU