Beaufort, LLC’s exceptional industry executives and seasoned consultants in operational, quality and regulatory affairs provide individualized compliance solutions designed to shorten implementation cycle time while keeping aligned with our clients’ business goals .
We can implement compliance methodologies from research and development to product launch and post-marketing surveillance in a timely, efficient manner. Our skilled team also can ensure a robust level of compliance by training and working with your employees to provide one or more of the following:
We can develop ICH Q9-appropriate compliance shields and defendable positions for numerous scenarios by conducting a thorough comprehensive risk analysis, then implementing remediation plans based on the findings.
Beaufort’s expert third-party auditors, all of whom have extensive medical device and pharmaceutical industry experience, can prepare your team to manage and effectively perform a compliance audit domestically and internationally for:
- FDA audits: ISO 13485, ISO 14971, cGMPs
- FDA QSIT inspection techniques
- All CFR requirements
- Internal cGMP audits
- External supply chain audits of vendors, contract manufacturing, and sterilization services, among others
FDA consulting and regulatory agency interaction management
Our consultants have more than 50 years combined experience working with the FDA to analyze, mitigate and resolve issues. Our deep understanding of how the agency thinks enables us to perform mock FDA audits domestically and internationally, identify compliance gaps and segregate risk issues.
FDA inspection management
Beaufort consultants are highly experienced in responding to both FDA 483 and warning letters with proven methodologies designed to minimize penalties while delivering the most appropriate response for the situation. We then provide project management to ensure that you meet your corrective action plan and commitment to the FDA.
Regulatory gap analysis
Our experienced practitioners can comprehensively assess your organization’s quality system and supply chain operations and identify regulatory requirement gaps for FDA ISO 13485 and ISO 14971, among others.
Root cause analysis and corrective actions
We use Six Sigma tools to perform effective root cause analyses and develop comprehensive corrective action master plans that will satisfy FDA regulations and ensure that your organization meets all regulatory obligations according to schedule.