Service List

KCS provides diverse services to pharmaceutical companies and academia. We are actively involved in setting standards for pharmaceutical industry through our work at USP and WHO Expert Committees and are aware of the latest regulatory trends and guidelines A representative list of available services is presented below:

  • Auditing analytical laboratories
  • Review of raw analytical data
  • Gap Analysis
  • Review of laboratory procedures, preparation of Standard Operating Procedures
  • Review of equipment qualification documents
  • Qualification of laboratory equipment
  • Review of laboratory investigations
  • CAPA issues
  • Support for addressing FDA 483 letters related to analytical chemistry and QA/QC laboratory issues
  • Support for remediating FDA Consent Decree commitments
  • Review of method development, method validation, method transfer documents
  • Review of cleaning validation methods, investigation of unknown impurities
  • Preparation of analytical protocols and review of protocols
  • Reviewing drug stability studies
  • Reviewing clinical and pre-clinical studies with humans or animals
  • Reviewing chemical and physical qualification of raw materials for regulatory submission
  • Reviewing reference standard programs and qualification of reference standards
  • Preparing forensic procedures, investigating issues of drug tampering and counterfeiting
  • Preparing procedures for analysis of toxic substances and drugs of abuse
  • Training chemists on the principles of analytical instrumental methods (HPLC, GC, TLC, ICP, FT-IR, UV, NMR, MS etc.)

And more...

P.O. Box 07194
Fort Myers, Florida 33919, USA
phone: +1 (845) 545-0767
email: pkucera1000@yahoo.com