Quality Management

Quality Management

We use proven quality management tools that are recognized throughout industry and within government as innovative and effective approaches to process improvements (Lean Six Sigma (LSS)).  Our team is ASQ Certified Six Sigma Black Belts wth years of experience working with organizations to improve processes to obtain maximum efficiency, quality, and sustained improvements.

Scientific and Technical Services

Our company offers experience in technical assessment and evaluations in the pharmaceutical and biotechnology industries.  We have the capability to design and implement quality systems to meet ISO-9000 certification requirements, along with a strong background in performing investigations, identifying root causes, and implementing CAPAs to improve compliance.  We have expert experience in drafting responses to regulatory agencies observations such as the FDA and EU.  We specialize in quality systems development, oversight and evaluation of contract manufacturers, testing laboratories and research organizations. We are proficient in all pharmaceutical arenas from drug product characterization to commercial scale manufacturing ranging from product testing to writing audit summary reports, including the following:

  • GMP/ISO-9000 certification requirements.
  • Chemistry, Manufacturing, & Controls (CMC) Experience
  • LIMS Experience
  • Track Wise Experience
  • Material Review Board Experience (MRB)

Certifications

  • American Society Of Quality (Asq, CQE)  – Certified Quality Engineer
  • American Society Of Quality (Asq, CSSBB)  – Certified Six Sigma Black Belt
  • American Society Of Quality (Asq, CMQ/CE) – Certified Manager Of Quality/Operational Excellence
  • American Society Of Quality (Asq, CPGP) – Certified Pharmaceutical Gmp Professional
  • American Society Of Quality (Asq, CQA) – Certified Quality Auditor
  • American Society Of Quality (Asq, CBA) – Certified Biomedical Auditor
  • Certified Six Sigma Green Belt
  • Certified Global Quality Auditor