Services
We provide comprehensive FDA compliance services to the pharmaceutical and medical device industries, including assistance with FDA readiness and strategic remediation of complex compliance issues.
RESPONSE
We offer FD-483 and Warning Letter Response assistance, as well as help remediating Quality and Compliance Issues
AUDITS
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FDA styled Mock audits, as well as remediation verification audits.
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Mock MDSAP
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For Cause Audits
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Baseline and Gap Assessments
REMEDIATION
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Remediating Quality Systems to fit your type and size of operations
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Create or Optimize compliant and sustainable systems
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Temporary Staffing of key personnel
TRAINING
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We also provide CAPA training programs, that include a quality and compliance training program for all levels of staff.
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We can provide cGMP training for leadership and for employees in Drug, Medical Device, or Combination companies
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We provide Risk training based on ISO 14971 and FDA's current interpretation of risk management