Pharmaceutical Manufacturing Assistance

Assisting organizations as they encounter facilities design, construction, or adaptation — or as they encounter facilities-related compliance problems. Through our powerful blend of compliance, regulatory, scientific, and technical expertise, we’re highly effective in:

• Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
• Developing environmental and processing-room requirements
• Recommending effective flow of materials, equipment, and personnel
• Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
• Addressing the facilities requirements of laboratory operations
• Performing factory acceptance testing of equipment (FAT)
• Conducting audits during construction and installation phases
• Qualifying facilities for sterile, low-bioburden, and non-sterile products
• Qualifying facilities for intermediates, APIs, and finished drug products
• Qualifying facilities for medical device components and finished products