Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. These companies turn to outsourcing to manage operations and tactical skills, and also help adopt best practices.

 

Successful execution comes through project monitoring, issue resolution, and risk management of the process through clear leadership. Regulatory Compliance Associates® Inc.’s team of experienced project management professionals organize and manage resources to ensure that projects are completed successfully, on-time, and within budget.

 

We offer staffing support in the areas of:

 

  • Project Management
    • On-site Project Leadership or Project Management Support
    • Design and Implementation of a Project Management Office
    • Project Planning Workshops
    • Project Assessment, Remediation, and Follow-up
    • Advanced Schedule Optimization and Management
    • Development and Implementation of Compliant Methods
      • Risk Management
      • Issues Resolution and Decision Tracking
      • Change Management
      • Performance Measurement and Tracking
    • Tool Selection for Program Portfolio and Resource Management
  • Staff Augmentation
    • Quality Assurance
    • Regulatory Affairs
    • Validation
    • Operations
    • Product Development
  • Consulting Support
  • Project-Based Solution Implementation

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