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regulatory, quality, & compliance

outsourcing solutions - regulatory, quality, and compliance

Randstad Life Sciences' Regulatory Affairs and Quality Assurance team provides global regulatory and auditing services to the pharmaceutical and biotech industry.  We understand the need to maintain 100% compliance with industry regulation and guidelines.

Our Regulatory Affairs and Quality Assurance services include:

  • Regulatory Strategy
  • Formulation and Review of Product Applications
  • Briefing Document Preparation
  • Label Development and Review
  • Investigative Site Audits
  • GMP/GLP/GCP Audits

Due to the criticality of balancing regulatory needs with internal efficiencies, organizations are taking a more comprehensive view of compliance.  Our Validation and Regulatory Compliance consulting practice provides services in quality systems and compliance, and can assist your organization with a range of needs including compliance with regulations such as 21 CFR Part 11.

Our Compliance services include:

  • Clinical Study Compliance
  • 21 CFR Part 11
  • HIPAA
  • Sarbanes-Oxley
  • Compliance and Quality Systems