Services

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

Project Management Support

• Support with project timelines
• Coordination and integration of CRO support