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Pharma, Biotech, Medical Device regulatory compliance consulting services from iEllipse
At iEllipse, our compliance consultants have a strong working knowledge of regulatory agency requirements and can help implement the necessary quality systems to meet those regulations applicable to your organization. Additionally, we have substantial experience helping clients with remediation when their quality systems fall short of meeting regulatory requirements.
iEllipse provides good manufacturing practice and compliance consulting to proactively help our clients avoid issues with regulatory agencies. We perform a gap assessment of your current quality systems to determine if there are any observations that expose you to enhanced regulatory scrutiny. We then provide recommendations for remediation and can provide hands-on support with implementation of those recommendations.
iEllipse compliance services augment your organization's own internal capabilities to prepare for, execute, and address compliance-related observations and deficiencies, thus mitigating regulatory risk.
Our customizable regulatory compliance services include:
- label Third-Party GMP Consulting and GLP Compliance Auditing
- label Mock FDA/International Regulatory Agency Inspections, and PAI Readiness
- label Due Diligence Compliance Inspections, Audits, and Assistance
- label Qualification and Validation
- label Response and Remediation Support (FDA 483 Observations, Warning Letters, Consent Decrees, etc.)
- label GMP and Drug Quality and Security Act (DQSA) assessments
- label Compliance audits for GMP, USP <795>, and USP <797>
- label cGMP Training