Services

Auditing  

• Data including Pharmacokinetics, Toxicokinetics, bioanalytical, clinical pathology, histopathology, statistics, CORE laboratories, echocardiography, angiography, cardiac data collection, electron microscopy, and others

• Final Study Reports

• Contributing Scientist Reports (as stated above)

• Facility Records

• Training Records

• Method Validation 

• Equipment and Computerized System Validation

• Data Integrity Audits for Process/Method Development Reports

• Equipment logs
      

Inspections

• Compliance Assessments

• Internal Facility 

• Contract Research Facilities Animal Testing

• Bioanalytical, Histology, Clinical Pathology, Electron Microscopy, FACS, Analytical and others

• 21 CFR Part 11

• Non-clinical Laboratory Study – in-life inspections, reports to Study Director and Management
     

Non-clinical Laboratory Studies

• Protocol development and review – device, drug and combination products

• Lead QA – Coordination of QA units for multi-site studies

• Advisor - Report design / organization
     

 Quality Systems Development

• Can include design and implementation of the system, applicable SOPs, forms, logs, staff training, maintenance

• Document Control

• Change Control

• Archive – facility and study records

• Master Schedule

• GLP QAU – Design and implementation of new Quality Assurance Units

• Quality Programs

• Laboratory Quality Control Programs

• Training Programs and Documentation
     

Standard Operating Procedures (SOPs)

• Analysis of existing SOPs

• QA review of draft SOPs for compliance

• Preparation of new SOPs  
    

Training  

• 21 CFR Part 58 GLP – New employee orientation, periodic refresher, basic and advanced

• 21 CFR Part 11 - Electronic records; electronic signatures

• Bioanalytic Laboratories
• Study Monitor/Study Director
• GLPs Medical Devices
• Computerized System Validation for the Scientist

• Customized to suit your needs
  

Validation

• Protocol and plan development and review

• In-life inspections

• Final package review

• Project management

• Master Validation Plans and Gap Analyses
• Part 11 Assessments

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