At Compliance Insight, we support top Biologic, Medical Device, Pharmaceutical manufacturing, and Clinical sites by providing effective GxP training as well as mission-critical quality assurance and regulatory affairs support.
The team at Compliance Insight leverages our industry knowledge and expertise to help life science companies and industries regulated by the FDA create new products, manage risk, and achieve remarkable growth.
We offer a comprehensive suite of compliance services and shape our practice to meet your needs. We take pride in providing clients with excellent service through every phase of the development process, and we are committed to helping you deliver safe, high-quality products to the market.
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11-50 employees
View all Compliance Insight, Inc. employees
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Pharmaceuticals
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497 Circle Freeway, Suite 230, Cincinnati, Ohio 45246, US
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2000
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Audit Preparation, Complete Mastery, Fda 483 Team, Fda Warning Letter Team, Gcp Compliance Services, Gmp/Gcp Training, Infusing Gxp Into Your Organization's Dna, Ra Compliance Services, The Three Sins Of Gmp Work Systems, Us Fda Compliance Specialists
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John Denniesg is the CEO of Compliance Insight, Inc.. To contact John Denniesg email at [email protected].
The decision makers in Compliance Insight, Inc. are Dia Hill, John Denniesg, Julie Waltz Gerlach, etc. Click to Find Compliance Insight, Inc. decision makers emails.
Compliance Insight provides comprehensive GxP training tailored for the Biologic, Medical Device, and Pharmaceutical industries. Our training programs cover Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and regulatory compliance essentials. We focus on infusing GxP principles into your organization's culture, ensuring that your team is well-equipped to meet industry standards and regulatory requirements.
Compliance Insight specializes in audit preparation services to help organizations navigate the complexities of FDA inspections. Our team conducts thorough pre-audit assessments, identifies potential compliance gaps, and provides actionable recommendations to address these issues. We also offer mock audits to simulate the FDA inspection process, ensuring your team is well-prepared and confident during the actual audit.
Our FDA 483 and Warning Letter teams are dedicated to helping organizations respond effectively to FDA observations and enforcement actions. We provide expert guidance on how to address the findings in FDA 483 forms and develop comprehensive corrective action plans. Our goal is to help you mitigate risks, improve compliance, and avoid future regulatory issues.
Compliance Insight primarily supports the Biologic, Medical Device, Pharmaceutical manufacturing, and Clinical research industries. Our expertise in GxP compliance, regulatory affairs, and quality assurance makes us a valuable partner for organizations operating in these highly regulated sectors, ensuring they meet the necessary standards for safety and efficacy.
Yes, Compliance Insight offers specialized GCP compliance services to ensure that your clinical trials adhere to regulatory requirements and ethical standards. Our services include training, audits, and consultation to help you establish robust GCP practices, manage risk, and maintain compliance throughout the clinical trial process.
The 'Three Sins of GMP Work Systems' refer to common pitfalls that organizations encounter in their compliance efforts, which can lead to regulatory issues. Compliance Insight addresses these sins by providing targeted training and consulting services that focus on best practices in GMP compliance. We help organizations identify weaknesses in their systems, implement corrective actions, and foster a culture of quality and compliance throughout their operations.
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