Raland Technologies
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Method validation is a necessity - but development of the methods is just as important.

Laboratory Development & Validation

Method validation is universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry. However, so is the development of those methods.

The acceptability of analytical data corresponds directly to the criteria used to validate the method. You need to be able to document accuracy, precision, selectivity, sensitivity, reproducibility, and stability to demonstrate the performance characteristics of the method are suitable and reliable for the intended analytical applications. At Raland Technologies, we have developed hundreds of methods for use in industry in compliance with state, federal, and ICH guidelines set by USP, IUPAC, ISO, and AOAC. We are here to help you every step of the way.

Areas of Expertise

  • Bioanalytical Testing (LC/GC/GCMS/LCMS)
  • Chemical Testing (LC/GC/GCMS/LCMS)
  • Microbial Testing (Bioburden, Gel Clot)
  • Physical Testing (Friability, hardness)

Services

  • Annual Lot Analysis
  • Equipment Specification and Selection
  • Equipment Installation and Validation (IQ, OQ, PQ)
  • Laboratory Information Management Systems (LIMS)
  • Laboratory Design, Installation and Qualification
  • Method Development (On-site)
  • Method Validation (On-site)
  • Remediation of Regulatory Issues (FDA 483)
  • Stability Program Development
  • Standard Operating Procedure Authoring
  • Technology Transfer
  • Training
  • Vendor Auditing