Tepnel Pharma Services is a UK based Contract Research Organisation that specialises in the provision of regulatory compliant analytical services in support of drug and companion diagnostics development. With over 30 years’ experience in pharmaceutical testing and molecular genetics we are committed to supporting and bringing value to customers’ projects.
Under inspection and approval of the MHRA and FDA, our GxP pharmaceutical testing and molecular genetic services include:
- cGMP Drug Development Support Services of EU Batch Release Testing, ICH Stability Testing, Raw Materials Testing and ICH Methods Development & Validation for small and large molecules.
- Pre-Clinical and Clinical Support Services of Biomarker Validation and Pharmacogenomics for clinical trial enrichment or stratification.
- Molecular Genetic Services that include gene expression, genotyping, copy number and epigenetic analysis using microarrays, qPCR, Sanger sequencing, fragment analysis and next-generation sequencing. Bioinformatics and Invader Plus assay design for RUO, LDT or regulatory approved diagnostic applications.
Our facilities are located in Edinburgh and Manchester and utilize state of the art equipment and applications.
Tepnel Pharma Services is part of Hologic Incorporated.