Analytical Methods

Services for analytical research and development: As your organization focuses on core business goals, you'll require a partner who has a history of providing consistently high-quality regulated compliance testing. Our team are focused on supporting product development, GMP manufacturing and distributio...

From our state-of-the-art analytical laboratories in the UK and US, our highly skilled analysts deliver comprehensive solutions to support drug substance (API) and drug product development programs. Analytical and microbiological testing solutions for clinical and commercial drug product supply are also pr...

PTI’s non-destructive inspection technologies verify container closure system integrity. Deterministic quantitative leak test methods for vials, ampoules, syringes, cartridges and auto-injectors. Applications include stability studies, clinical trials, quality assurance testing and statistical process cont...

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)

We provide Method Development and Method Validation for new analytical methods or Method Transfer for Routine Testing according to existing validated methods for raw materials and final products. QACS is GMP certified.
• performed with UPLC-MS/MS, GC...

Lomapharm GmbH provides wide range of services including analysis service. It involves chemical and physical analysis of raw materials, intermediate and finished products according to national and international specifications as well as customer-specific information (microbiological purity, stability t...

With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterise inhaled delivery platforms, especially DPI, pMDI and nebulised products.

To ensure seamless support for your development...

To meet your analytical needs, Quality Assistance provides you with scientific and technical support for the development of your New Chemical Entities. Our added-value brings together a sound expertise in small molecules analytical development with state-of-the-art facilities and equipment, all o...

With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates. Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full ana...

Take no risk with your analytics when developing new therapeutic monoclonal antibodies. Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical ...

Thanks to 35 years’ experience in analytical sciences and all our laboratories on one site (Mass Spectrometry, Physico-chemistry, Cell Biology, MolecularBiology and Microbiology), Quality Assistance covers all the analytical technologies needed to support your drug development process i...

Quality Assistance covers all the analytical technologies needed to support your drug development process: CMC (Quality) studies to be perfomed, including Ab characterisation, development and validation of analytical methods, stability studies and batch testing. For Bioanalysis to be performed in Non-clini...

The screening test consists in the assessment of which nitrosamines are present in the drug product below an acceptable limit, defined according to the recommendations of EMA. 

These limits are calculated based on the acceptable intake (AI) of each nitrosamine. QPLAB has a LC-MS/MS method tha...

QP Declaration
QPLab will evaluate the information regarding active substances manufacturing sites of the product, to assess the EU GMP compliance and issuing the QP Declaration.

QP Batch Certification SetupIn this step QPLab will have a complete oversight ...

Spark-Lab Chemical Analysis Department performs qualitative and quantitative analyses in response to the needs of, above all, the chemical industry and related sectors. Research is carried out with the use of high-end, qualified measurement equipment. Routine analyses carried out in Spark-Lab me...