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We’re Services

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  • Program Management

Full Time or Fractional Program Management to support larger company initiatives across multiple projects managing budgetary and interdependencies between projects.  Ensuring resource capacity and availability. 

  • Project Management

Full Time or Fraction Project Management to support specific project scope.  Our Project Managers can manage the budget and deliverable schedules.  Either as a stand-alone PM or integrated into a project team to ensure the project is successful, on time and in budget.

  • Auditing (Mock FDA)
  • Warning Letter Response
  • Remediation Plan Development
  • Submission Support
  • CMC Development Support
  • Post Market Surveillance
  • Clinical Trial Support
  • Quality Management System development and deployment
  • Audits internal and vendor
  • Compliance Gap Assessments
  • Quality Management and oversight
  • Remediation Plan execution
  • Environmental Monitoring Plan Development
  • Batch Record Review
  • Deviation Investigation
  • Corrective Actions Preventative Actions support
  • Training
  • Training Content Development
  • Training Program Development
  • Process Validation
  • Method Validation
  • Cleaning Validation
  • Computer System Validation
  • Technical Transfer
  • Critical Utilities and High Purity Water Systems
  • Validation master Planning
  • Media Fills
  • Factory and Site Acceptance Criteria
  • Manufacturing Equipment
  • Laboratory Equipment
  • Packaging Equipment
  • Facility and utilities
  • Temperature Mapping
  • Factory and Site Acceptance Criteria/Testing
  • Regulatory Affairs Support
  • Calibration Services
  • HEPA Filter Testing and Certification
  • Microbiological Testing Services
  • High Purity Water Services
  • Pharmacy USP NF <797 & 800> Compliance
  • Mechanical Design and Installation
  • Factory Acceptance and Site Acceptance Testing
  • ISO and GMP Certifications
  • Pharmaceutical cGMP - USP 800 - USP 797 - Low Humidity Cleanroom Design Build