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Strategic Audit Consulting |
| Polaris’ experienced staff is able to provide clients with strategic consulting in the regulatory and manufacturing areas, including: |
- Developing regulatory strategies and strategic plans for interactions with the FDA
- Reviewing QA policies and procedures
- Developing strategic internal and external audit plans
- Serving as advisors for Project Managers and QA Managers
- Training staff in regulatory requirements and research techniques
- Conducting process flow assessments for CGMPs
- 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
- Writing CMC portions of INDs and NDAs
- Writing and reviewing QA policies and all aspects of CGMP procedures
- Assisting personnel at new clinical sites in establishing efficient operations
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200 Commonwealth Court, Suite 101 
