Developing a method to analytically test a potential API is an important step in the drug development process. However, unless your method follows certain guidelines, the path toward regulatory approval will be short-lived. In order for methods to be validated, one should consider accuracy, precision, specificity, as well as the limit of detection, limit of quantitation and the linearity and range. Whether using standard methods or non-standard methods, a variety of companies offer analytical method validation services. A majority of the companies listed below offer both analytical method and validation services.
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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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