Strategic Audit Consulting:
BioAccurate 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