Stability Testing

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...

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...

Creating pharmaceutical reference standards to customer specification has always been at the heart of the Mikromol business. We understand that you are constantly discovering new actives and impurities of interest - each year, our dedicated, highly-qualified customs team produces several hundred new materi...

Grünenthal GmbH offers a selected range of products which includes Betahistine diHCl, as API, bulk tablets and/ or finished dosage form. Please contact us for more information.

Method Development and validation
Stability Studies
European testing & batch certification

QACS Labs offer drug development services. Pharmaceutical testing includes pharmaceutical stability testing, storage stability services and custom solutions based on international standards. We test API’s, raw materials and final products in recommended environmental storage conditions such as Temperature,...

Our services include: • Quality controls • Investigation studies • Absorption studies • R&D and validation activities • Stability & storage • Cleaning and disinfectants validation Download our brochure: https://bit.ly/48HKnVs

Analytical Services: QC Chem/Microbio, stability, etc.

Conscio offers GMP-certified and ICH-compliant chemistry, manufacturing and controls assays (CMC) as well as analytical support during validation of manufacturing processes. Samples are analyzed by approved and validated methods for routine batch testing, stability studies, analyses of high potency product...

Xedev provides wide range of analytical tools which includes : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : Friability, disintegration, hardness • Residual solvent determination : KF, LOD o...

• Genexol®PM Inj.(Paclitaxel)   • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...

Imagine design and prototyping Services that enable accelerated market introduction with increased accuracy in stability testing using the most cost-effective blister film to meet your requirements. Contact us for more information.

MedPharm leverages its 20 years of experience to help develop and validate IVRT methods for its clients. We successfully perform IVRT based on FDA and EMA guidelines and continue to influence how these methods are utilized in regulatory submissions.

IVRT is the established method recogniz...

Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.

Our services include:

Analytical
• Raw material and drug product...

The Pharma Servicdes / Lichtenheldt development Department (LDS) accompanies and advises our customers from product idea through galenic development and through the registration into the routine production. For product development and scale up Lichtenheldt has its own dedicated staff and laboratories, ...

Healthy food is becoming more and more popular. Thus, it comes as no surprise that the demand for natural botanicals is steadily increasing. They give each product an appealing, unadulterated appearance, ensure authentic taste – and create the opportunity to declare it as a natural food. Embedded i...