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Are You Ready?
Are You Willing to Gamble?
Have You Done Everything Possible to Prepare for Your
Next FDA Inspection?
Do you rely solely on in-house staff to prepare? Obtaining an independent review is critical to ascertaining your site’s true readiness. Our regulatory professionals quickly identify your vulnerabilities and prevent or mitigate them from becoming significant compliance issues. Our systematic, proven, risk-based approach and experiential learning goes beyond the traditional “mock audit” to prepare SMEs and staff to competently respond to all investigator queries. Avoid inspection surprises. Prepare early, often and thoroughly.
Inspection Readiness services:
The FDA has increased its focus on enforcement by hiring more investigators and has increased the number of Warning Letters issued.
In our experience:
You’re experienced and may have a great in-house team. So, you’re thinking, why not prepare for an inspection on your own? Just as GMP requires an independent review of your quality records, you also need an independent and unbiased review of your site’s readiness.