Business Process Outsourcing in Healthcare Regulation
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Project Management Support and Workplace Improvement

  • Business process outsourcing and workplace automation
  • Enterprise support in life science, insurance and healthcare practice
  • Web based electronic documentation of clinical and performance data
  • Tactical and strategic project Support and management of project timelines
  • Coordination and integration of CRO support

Research and Development

  • Preformulation and formulation development
  • Validation of analytical methods
  • Manufacturing development and scale-up concepts
  • Stability assessment, statistical analysis, and SAS programming of chemical data
  • Ruggedness and robustness of formulation and methods
  • Data Management and control
  • Antimicrobial preservative efficacy
  • Characterization of particulates in product

Medical Writing and Regulatory Document Management

  • Preclinical Reports, Investigators' Brochures, Integrated clinical and statistical reports
  • Regulatory document management
  • IND/NDA Preparation, statistical analysis of integrated reports (safety and efficacy)
  • Case Report Form Design and Production
  • Investigators' Meeting Management
  • Subject narratives for SAE reporting
  • Annual reports and study updates
  • Manuscripts publication management

Quality Assurance/Quality Control

  • Site and document audits
  • Vendor qualification
  • Manufacturing and laboratory audits
  • Data and Database audits
  • CFR 21 GMPs for industry