Quality Management System Strategy and Implementation

Audits: GMP, GLP, GCP and ISO

Data Integrity Audits

Scientific and Regulatory Due Diligence

Technology Transfer Strategy, Oversight and Monitoring

Technology Readiness Assessments (TRAs)

Procedure Writing and Training

Training: Including GxP, Data Integrity, FDA Inspections

FDA GMP Compliance Assessments

Market Research and Analysis

Subject Matter Expert Staffing

Quality and Regulatory Organization Design