Compliance - Getting You Back
In 2011 the FDA Averaged Approx. One 483 Every 52 Minutes
Multi-National Compliance to Regulations
and Expectations can be difficult to
understand and navigate. Doing this while
maintaining balance, cost effectiveness,
quality, logic, and efficiency is even harder.
Our personnel and external network
includes ex-government and industry
experts who have brought companies back
from Consent Degrees.
We can provide you with:
- FDA and International Compliance
- Quality System improvements
- Draft responses to 483s, Warning Letters,
and other Regulator observations
- Mock Pre-Inspections
- Training on Inspection Management and
- General GMP Training.
- Remediation Management
- GCP Compliance
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