Nelson Pharma Services LLC

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I have 23  years of experience managing pharmaceutical analytical laboratories. I have worked with dozens of pharmaceutical companies large and small. I will implement creative and efficient solutions to your problems while prudently managing risk.

• Data integrity investigation, India – Bioanalytical testing facility remote.
• Data integrity supplier program, Gilead USA – Finished product manufacturer, remote.
• FDA warning letter response for investigations, India – Sterile finished product manufacturer, remote.
• Laboratory investigations procedure enhancement, Europe and USA – Sterile combination product manufacturer, remote.
• FDA warning letter response for analytical test method validation deficiencies – India API and finished product manufacturer, remote.
• FDA 483 response for HPLC/GC manual integration observation, USA – Generic parenteral production facility, remote and onsite.
• Biosimilar launch, Aprogen Korea – mAb production facility new product launch including HPLC methods validation and transfer. Onsite and remote.
• FDA warning letter remediation for laboratory OOS investigation deficiencies, Canada – Solid and liquid dosage forms at multiple sites, remote.
• QC stability data review backlog, McKesson USA – Blister repackaging facility, onsite.
• Forensic laboratory HPLC/GC/UV data integrity investigation, India – API manufacturer, onsite.
• Product transfer, Patheon/Thermo Fisher U.K. – Sterile inhalations manufacturer, onsite.
• Forensic laboratory HPLC/GC data integrity investigation, India – Solid oral dose manufacturer, onsite.
• Product stability investigation, Teva USA – Transdermal manufacturer, onsite.

• Watson/Actavis/Allergan/Teva: 12 years as Director of Quality Control.  Experience with quality management for manufacturing of transdermals, gels, topicals, oral suspensions for US, EU, Australia, Switzerland, Turkey, Japan.
• AAI International: 11 years as Associate Director/Director of Pharmaceutical Product Analysis overseeing analytical R&D projects for multiple drug companies.

• Laboratory Investigation
• Inspection Readiness
• Laboratory Forensics
• Method Transfer
• Operational Excellence
• Data Integrity
• Stability
• Deviations
• Technical Writing
• Method Validation
• Environmental Monitoring
• Purified Water Systems
• Material Nonconformance
• Instrument Qualification
• Calibration Programs
• Elemental Impurities

• Mobile: +1-385-645-3685
• email: eric@nelsonps.com

Nelson Pharma Services LLC

9771 SE Spyglass Dr. Happy Valley OR 97086