Analytical/Quality Control (QC) Support Audits and Assessments CAPA and Deviation Investigation and Resolution Clinical and GCP Support Compliance CMC Support Design Control FDA Strategies Formulation Development GCP, GLP, GMP, ISO, and QSR Compliance Manufacturing Compliance Oversight Manufacturing Engineering and Support Methods Development and Validation DDMAC: Promotional Advertising and Labeling Packaging Engineering and Validation

Medical Affairs and Pharmacovigilance Microbiology Support Part 11 Compliance Pre-Approval (PAI) Auditing and Training Project Management Quality Systems/QA Development and Support Regulatory Support Risk Management and FMECA Technical and Document Writing Training Programs: Standardized or Customized Validation: Cleaning, Equipment, Process, Software Validation: Equipment and Software Vendor Management