With more than 1300 validated methods, CEDRA is at the forefront of the industry in the development of bioanalytical methodology. We first offered LC-MS analytical services in 1990, and have remained on the cutting edge by acquiring the latest in LC-MS-MS instrumentation and multiple platforms.
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GLP Capabilities
GLP is an integral part of everything we do at CEDRA, from SOPs to validated computer systems to in-process inspections and audits.
Our Quality Assurance (QA) Unit works as an independent auditing unit, reporting directly to the President/CEO. The QA Unit monitors daily activities to ensure FDA compliance.
Our Quality Control (QC) Unit reviews data and reports (validations as well as sample analysis studies). The QC Unit confirms that the overall quality is of the highest level, meeting industry standards, and compliant with CEDRA or sponsor SOPs.
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Method Development
CEDRA's dedicated scientists have extensive experience in the development of bioanalytical LC–MS–MS methodology in a variety of matrices (plasma, urine, tissue). We can develop a custom method for your compound(s) or we can transfer or modify your existing method.
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GLP Validations
All of CEDRA's validations are conducted under CEDRA and/or sponsor SOPs. Validations are in accordance with the FDA's Guidance for Industry titled, "Bioanalytical Method Validations" issued in May 2001 and the workshop/conference report, "Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays," issued 2007.
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Bioanalysis
CEDRA has built its reputation by providing quality bioanalytical services at competitive prices with rapid turnaround. With numerous LC–MS–MS instruments dedicated to sample analysis, CEDRA can analyze approximately 50,000 samples per month. Our extensive use of laboratory automation allows us to process samples quickly. In fact, 75% of our methods are developed using automated technologies.
CEDRA specializes in the following:
- Retinoids
- Narcotic analgesics
- Peptides
- Enantioselective assays
- HIV compounds (RTI and PI)
- Oncology compounds
- Low-level quantitation
Resources
click here to see our Bioanalytical resources
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Custom Synthetic Chemistry/Reference Material
CEDRA routinely synthesizes and characterizes bioanalytical reference standards, including deuterated and enantiomerically pure materials and metabolites.
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Client Relationships
At CEDRA, we still work with our very first client. We're very proud of that fact, but it's no accident. All of CEDRA's programs and processes are designed to build trust and long-term relationships with our clients.
- Timelines—CEDRA is committed to meeting clients' needs in a responsible and timely manner. Project teams develop a sense of ownership of their studies, as well as a sense of partnership with their clients. This partnership is enhanced by a corporate culture that promotes excellence through teamwork—our people will pull together and do what it takes to meet even the most challenging deadlines.
- Communication—An open dialogue with our clients allows us to design and implement studies that met their specific needs. In addition, ongoing communication is maintained through regular project updates so clients always know their project's status.
- Team structure—CEDRA has developed a unique team structure to promote flexibility, accountability and efficient use of resources. Team performance incentives are based upon client satisfaction measurements. Factors include establishing client needs and meeting timelines.
List of Methods
To download our most current Methods List, please click here. You will need Adobe Acrobat to view the file.
