Strategic Consulting for FDA Compliance
& Quality Assurance

"You can’t audit in quality”, as the saying goes. While a comprehensive auditing program is an important component in any QA program, quality must be built in from the beginning.

Polaris’ experienced quality team can act as an extension of your own by providing strategic consulting in the regulatory and manufacturing areas, including

• Writing and reviewing QA policies, manuals, and procedures
• Performing gap analyses against regulations
• Serving as advisors for Project Managers and QA Managers
• Training staff in regulatory requirements and research techniques
• Conducting process flow assessments for CGMPs
• Developing clinical trial materials labeling
• Conducting due diligence of manufacturing operations and processing systems
• Serving as liaison among contractors (API manufacturers, laboratories, manufacturing, and distribution centers)
• Providing a “man in the plant” for manufacturing support
• Assisting start-up companies with ramp-up activities related to manufacturing and quality assurance, including development of internal staff and/or outsourcing
• Developing regulatory strategies and strategic plans for interactions with the FDA
• Writing CMC portions of INDs and NDAs
• Assisting personnel at new clinical sites in establishing efficient operations

You have your own set of strengths to leverage, and your own constraints to contend with. We can help you identify knowledge gaps or resource shortages, and work with you to bridge them.