Compliance Insight provides strategies to prevent or resolve compliance issues. Our highly experienced team offers hands-on support to ensure that corrective and preventive action are identified as well as performed quickly and efficiently. We are dedicated to developing and maintaining a quality centered GXP focus.
Our Services Include
- FDA Compliance Issue Resolution – We can guide you through all your FDA Compliance Issues including: FDA Audits, 483 / Warning Letters and Consent Decrees.
- GMP & GCP Training – Our training division will help you create an effective and efficient training program. Who wants to sit down an read SOP’s? Our goal is to cultivate and environment that drives compliance AND higher job satisfaction.
- Virtual QA – The demands of having your own Quality Assurance Department may be more than your organization can handle. We specialize in running Quality Assurance for companies so you can stay on schedule, in budget and compliant!
- Audit – We can quickly help you with your audit needs including due diligence, vendor, GMP Gap, and Pre-Approval Inspection audits.
- Regulatory Filing – Completing your FDA mandatory regulatory filing can be complex and time consuming. Let us help you complete your regulatory filing so you stay compliant!
We also offer targeted bilingual services for Spanish speaking areas of the US, Latin America and globally
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