ICH Stability Studies

ICH Stability Studies

Stability Chamber (IQ/OQ/PQ, annual calibration): temperature, humidity, light Stress testing, accelerated, intermediate, long-term, etc. Stability sample management Stability testing: chemical properties, physical properties   Stability Management Development of...
ICH Stability Studies

Formulation Development

ChemPartner’s formulation group specializes in the development of novel solid and liquid dosage forms. Liquid dosage forms such as oral solutions, suspensions, and injectables have become the focus for pre-clinical safety evaluation in the industry. We are proud to...
ICH Stability Studies

Pre-Formulation Development

Pre-Formulation Support: Salt selection screeningPolymorph screeningThermal propertiesSolubility profilingHygroscopicityMicroscopy and morphologyCrystallinity evaluationFlowabilityParticle size and distribution measurementBulk and tap densitiesLog P/Log D and pKa...
ICH Stability Studies

Analytical Development

With extensive scientific knowledge and experience with the regulatory requirements of both the international and domestic markets, ChemPartner’s analytical development group provides strong support for drug substance and drug product development. The quality of our...
ICH Stability Studies

Process Safety

Process safety and hazard assessment are a vital aspects of development. ChemPartner has an experienced and dedicated team responsible for process safety and hazard assessment evaluation. The team performs process hazard analyses and preliminary hazard and operability...
ICH Stability Studies

Process R&D Services

Our experienced teams at ChemPartner provide creative and innovative chemistry solutions for our clients’ chemical development projects. The quality of our chemical development services comes from innovative scientific approaches, effective communication,...
Molecular Pathology: Immunofluorescence (IF)

Molecular Pathology: Immunofluorescence (IF)

Immunofluorescence (IF) staining is used to detect and localize antigens (e.g., proteins) in cells or tissue sections by using of fluorescent dye-conjugated antibodies or non-antibody methods of fluorescent staining (eg. DAPI). Compared with immunohistochemistry...
Molecular Pathology: Immunofluorescence (IF)

Molecular Pathology: Immunohistochemistry (IHC)

Immunohistochemistry (IHC) is used to detect and localize antigens (e.g., proteins) in cells or tissue sections by exploiting the principle of antibodies binding specifically to antigens in biological tissues. ChemPartner has accumulated extensive hands-on experience...
Molecular Pathology: Immunofluorescence (IF)

Histopathology

ChemPartner provides proficient pathological service including animal necropsy, tissue processing and embedding, blank section preparation, H&E staining, special staining, image collection, data analysis, and final reporting. Stained slides are reviewed and...
Molecular Pathology: Immunofluorescence (IF)

Regulatory Filing

ChemPartner provides IND filing packages and helped file hundreds of US FDA submissions for our clients. Robust in vitro/in vivo ADMET packages in support of regulatory submissions Experienced in both US FDA and NMPA assay design requirements and...