When developing a new drug, there is a good chance there won’t be a well-established method in place for analytically testing the physical and chemical properties of a potential API. Also, when existing compounds are used together in a new formulation, analytical method development might be necessary in order to test the drugs’ interactions with each other, the formulation excipients or biological fluids. Whether you need help with dissolution method development or for analytical testing using HPLC, LCMS or any number of immunoassays, there are many companies that provide analytical method development services. In addition to method development and validation services, many of these companies have qualified scientific staff to perform analytical tests once the methods have been developed and validated.
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- Analytical Testing Expertise: Inquire
- Analytical Testing Expertise:
- Analytical Testing Expertise: Inquire
- Company Services: Clinical trial materials to full scale, high volume commercial production, Formulation and product development, Analytical services, Clinical supplies, Technology transfer, Unique packages and delivery systems, Sample and professional use sizes, Tertiary packaging / kit pack-out
- Employees: 250+
- Year Founded: 1983
- Facility: 165,000 square foot state-of-the-art facility
- Area(s) of Expertise: Rx Pharmaceuticals, OTC Drugs, Therapeutic Skin Care, Animal Health
- Analytical Testing Expertise: Chromatography (LC and GC); Dissolution (UV and LC finish); Moisture (Karl Fischer); Particle Size (Malvern); Ion Chromatography (Dionex); AA/ICP; FTIR; Titrations; Particulate Matter (HIAC); Cleaning Methods (LC and TOC)
- Employees: 230+
- Year Founded: 1994
- Analytical Testing Expertise: Dissolution and drug release profiling; Forced degradation studies
- Company Services: Pharmaceutical Development Services (PDS); Contract Manufacturing and Packaging
- Employees: +4000
- Year Founded: 1974
- Annual Revenues: US$ 671.2M (2010 FY)
- Key Personnel: James C. Mullen, Chief Executive Officer
- Analytical Testing Expertise: In-process analysis; Bulk release testing; Drug product release testing; Stability monitoring
- Employees: 93 (est)
- Year Founded: 2008
- Analytical Testing Expertise: Assay and Related Substances; Dosage Uniformity (Content uniformity, weight variation); Absence of Active; ID (FTIR, HPLC); Dissolution Test Methods; Moisture; Microbial Limits
- Facility: Xcelience operates out of a cGMP compliant, DEA licensed facility located in Tampa, Florida, one of the most desirable cities in the world.
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