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Tepnel Pharma Services

Tepnel Pharma Services is an independent contract research organization (CRO) that specializes in the provision of pharmaceutical testing and molecular genetic services in support of drug development. Our CRO pharmaceutical testing facilities are located in the UK and are MHRA and FDA inspected. With over 30 years of CRO experience in pharmaceutical testing and molecular genetic services, our staff are committed to delivering high quality analytical support on behalf of our clients. Please visit the Tepnel Pharma Services website!

Visit the Tepnel Pharma Services website!

About

Under inspection and approval of the MHRA and FDA, our pharmaceutical testing and molecular genetic services include:
- Molecular Genetic Services.
- cGMP Drug Development Support Services.
- Clinical Support Services.

Support

For cGMP Services and Clinical Support Services, please contact:
Tepnel Pharma Services
Appleton Place, Appleton Parkway
Livingston, West Lothian
EH54 7EZ. UK
Tel: +44 (0)1506 424270
Fax: +44 (0)1506 424280
pharma@hologic.com
www.tepnelpharmaservices.com

For Molecular Genetic Services, please contact:
Tepnel Pharma Services
Heron House, Oaks Business Park
Crewe Road, Wythenshawe
Manchester. M23 9HZ. UK

Tel: +44 (0)161 946 2200
Fax: +44 (0)161 946 2211
pharma@hologic.com
www.tepnelpharmaservices.com

Molecular Genetic Services

As a Molecular Genetic Services provider, we offer a broad range of services for biomarker discovery, assay development, assay validation and companion diagnostics development in support of genomic research, clinical trials, translational research and personalized medicine studies. We also offer a complete biomarker discovery and validation package from initial study design through companion diagnostic development.

Molecular Genetic Services include extraction from multiple samples, gene expression, SNP genotyping, copy number and epigenetic analysis using microarrays, qPCR, Sanger sequencing, fragment analysis and next-generation sequencing. Our multidisciplinary staff of experts can support all stages of the companion diagnostics development process, including design control, kit manufacturing, validation studies and production. All services can be run as “research use only” or as regulatory compliant.

Clinical Support Services

Tepnel Pharma Services provides quality assured, GCP-compliant solutions for all of your clinical and biomarker requirements. With increasing requirements to establish clinical validity and utility of both biomarkers and diagnostics, we offer a bespoke solution for early stage drug development, patient stratification in support of clinical trials and companion diagnostic development.

Key services include:
- Early stage drug development.
- Patient stratification in clinical trials.
- Biomarker validation.
- Companion diagnostic development.

As an experienced provider of molecular genetic services, we believe in developing and promoting a successful partnership with our partners such that we become an extension of your own laboratory.

cGMP Support Services

Tepnel Pharma Services specializes in providing pharmaceutical testing in support of drug development. Our cGMP pharmaceutical testing facilities are located in Livingston, Scotland, where our multidisciplinary team of experts is committed to providing laboratories the most innovative and effective technologies from sample receipt through report delivery. With more than 30 years of CRO experience in pharmaceutical testing, we provide regulatory-compliant analytics in support of small- and large-molecule APIs, IMPs and finished products. We remain steadfast in our focus on continually evaluating development processes to ensure maximum value and quality on behalf of our clients. Under inspection and approval of the MHRA and FDA, our pharmaceutical testing services include:

Lot and batch release testing – We can provide regulatory-compliant batch release testing and QC testing of pharmaceuticals and biopharmaceuticals for release in European and global markets. Our flexible, rapid service ensures quick turnaround, shortening the time from product manufacturing to commercial availability.

ICH stability testing and storage, small molecule and biopharmaceutical – Our on-site analytical chemistry and microbiological support, together with a range of validated cabinets and chambers, ensures that your ICH stability testing projects are carried out efficiently and in compliance with ICH Q1 guidelines.

Pharmacopeial and raw materials testing – We provide comprehensive raw materials testing, pharmacopoeial testing and microbiology testing of excipients and ingredients.

ICH method development and validation – Services include analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.