• Design and write protocols
• Technical evaluation of protocols
• Data reviews
• Study report preparation
• Technical review of reports
• Preparation of report summaries
• Preparation of regulatory rebuttals
• Fulfill study monitor/director responsibilities
• Identify & qualify contractors

Standard Operating Procedures Development

QAI offers customized SOPs, either as part of the establishment of a new GLP program, or to respond to punctual needs of its clients.  In particular, QAI has developed a great number of SOPs under the following chapters:

• Administration
• Standard Operating Procedures
• Quality Assurance Unit
• Protocols
• Documentation
• Test and Control Articles
• Test, Control and Reference Substances
• Study Reports
• Archives
• Laboratory Procedures
• Laboratory Equipment
• Field Procedures
• Field Equipment

These SOPs are available for use after minimal customization.

_Case Study