1972 to 2020:
A Heritage in Pharma Services, Supporting Drug Development, Improving Patient Outcomes
Tepnel Pharma Services Limited is pleased to announce that 2020 sees the re-institution of the Tepnel brand as a privately owned MHRA, FDA and EMA approved GMP Quality Control (QC) laboratory, with a pure pharmaceutical focus.
As a privately owned company, based in the vibrant Scottish Life Sciences community, our people are beginning a journey to provide innovative pharma services which help in the advancement of safe medicines and the creation of a value based healthcare system which improves patient outcomes. The heritage of the Tepnel Pharma Services brand extends back to 1972, and during its lifetime has trained pharmacists, served as an OMCL as a part of the Medicines testing scheme, been GMP, GLP and CGP accredited by various global regulatory bodies, supported Biomarker research but always with a focus on pharmaceuticals and their specific testing requirements.
In agreement and with support from Hologic Inc., as of 4th of March 2020 the Tepnel brand will be transferred to local management ownership. Creating a company based in Scotland, owned in Scotland and scalable in Scotland.
Throughout our history our commitment to Life Sciences in Scotland and our core values have remained the same:
We are successful because of our People
We are Progressive in our way of thinking
We believe in our Principles
With a philosophy of reciprocity, we are committed to creating value-based
propositions and solutions for our employees, stakeholders, patients and clients.
With over 30 years’ CRO experience of pharmaceutical testing, we provide regulatory compliant analytics in support of small and large molecule APIs, IMPs and finished products. We are committed to continuous improvement and development of our processes to create value propositions on behalf of our clients. Under inspection and approval of the MHRA and FDA, our pharmaceutical testing services include:
Lot and Batch Release Testing
Confirming every batch of medicine has the correct composition through documented and validated laboratory tests, before QP certification and release.
ICH Method Development and Validation
Method development and validation for a variety of platforms including HPLC, GC, UPLC, Dissolution and Elisa, support product development of a variety of pharmaceuticals, APIs and formulation types.
Raw Material Testing
Comprehensive testing as per pharmacopoeia (USP, EP, BP and JP) and to your specifications for analytical chemistry and microbiology for raw materials, APIs, finished products, packaging materials and medical devices.
ICH Stability Testing and Storage
Gathering data to determine an overall stability profile as described in ICH Q1A(R2) on Drug substance, drug product, combination devices, and raw materials.