Stability Testing of Drugs

Testing for extractables and leachables: Our scientists perform extractables and leachables testing based on regionally specific guidelines (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <665>, <1663>, &l...

Solvias offers the complete range of stability studies according to ICH guidelines for drug development and follow-up stability studies, covering all ICH standard storage conditions as well as low temperature storage. All our processes take place on one connected site, where there is a high degree of QC ex...

CritiTech provides a suite of material characterization and analytical services to support our clients drug development projects from proof-of-concept through cGMP production. Our testing data and documentation is reviewed by experienced technical and quality staff to ensure it can be used to support regul...

With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlle...

Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio...

We deliver responsive QC analysis for complex biologic products from our cGMP laboratories. Our scientists develop and validate methods or perform technology transfer of a sponsor's method for a wide range of analytical methods required for batch release testing. We also routinely carry out testing to Phar...

Monoclonal antibody therapeutics: We continually invest in advanced analytical instrumentation that allows us to deliver mAb analytical data with the highest degree of sensitivity, accuracy and resolution. Our experience spans recombinant monoclonal antibodies and related products such as biosimilars, ...

Analysis and characterization of protein aggregates: The services provided by our experts include a range of protein aggregation analysis techniques that are used to detect and quantify aggregates in solution in support of formulation development, quality control, stability studies, comparability, rel...

To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...

Providing Analytical method development, validation and stability study from Phase I-III to commercial prodcution and registration.

Allyone's Stability Chambers have a reputation to quickly achieve & maintain the defined setpoint to simulate the condition perfectly & flawlessly with extraordinary control on both Temperature & Humidity along with outstanding uniformity.

Our Stability Chambers are conceptual...

Allyone has a long & rich experience of manufacturing state of the art Cooling Cabinets/ Cold chambers which are the most trustworthy equipment maintaining the exact set point, assuring absolute uniformity as they are meticulously designed & built for optimum performance keeping in mind environment...

As the evaluation of stability is a critical aspect of drug substance and drug product testing, Integrated Analytical Laboratories offers Stability Services and Sample Testing to our partners.  Whether you have predetermined stability protocols or require IAL to develop the protocol, IAL will be an im...

• Premium Extracts – for your project Our extract portfolio includes both extracts in line with the ISO 22000 and/or Ph.Eur monograph for the pharmaceutical industry, and extracts for the food industry. From A for Althaea (marshmallow) to V for Vaccinium (cranberry) - we offer you a sophisticated and inn...

Inkemia IUCT Group offers a wide range of services which includes isolation and characterization of impurities. Features: it includes development and validation of analytical methods for determining related substances; impurity profiling; getting forced degradation impurities; isolation and purification of...