Project Management Services

    • Project Management

    • Project Execution Planning

    • Schedule Development

    • Fast Track Validation/Qualification Scheduling

Interim Manager Services

Interim Management of Department & Teams:

    • Manufactruing Department/Teams (Sterile Filling,

      Compounding, Solida, etc.)

    • Process and Plan Engineering

      Department/Teams

    • Validation and Qualification Department/Teams

    • Quality Unit Department/Teams

GXP-Compliance

    • Business/GMP Process Analysis

    • Process Developmentand Improvement

    • Standard Operation Procedures,

      Generation and Update Services

    • Quality Manuals,

      Generation and Update Services

    • GAP Analysis in regard to EU/FDA Requirements

      and Expectations

    • GXP Trainings and Workshops

    • Trending Concepts

    • Documentation Structure

Validation Services

    • Process Validation

    • Cleaning Validation

    • Analytical and Sampling Method Validation

    • Qualification of Equipment & Utilities

    • Commissioning of Equipment

    • Verification and Validation

    • Re-validation and Re-qualification

    • Tracebility Matrices

    • Risk Assessments

    • Validation Documantation,

      Reviews, Reports and Summaries

    • GAP Assessments

Quality Assurance

    • Q-Systems Reviews

      Development & Optimization

    • Validation Master Plans Generation and Update

      Service

    • Contamination Control Strategy

    • Risk Assessments (GXP, Raw Material, Process,

      Cleaning, Utilities, Equipment, etc.)

    • Procedures and Documentation Review and

      Upgrade Services

    • Audit Preparation & Support

    • Auditing Services