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Regulatory Compliance Management
Regulatory compliance is crucial to maintaining your business’s reputation and operational integrity. With infoVish’s Regulatory Compliance Management services, you can confidently navigate complex regulations, minimize risks, and ensure your business remains compliant in an ever-changing landscape.
Safeguard Your Business and Simplify Compliance by Operating in a Secure and Reliable Environment
Our Regulatory Compliance Management Services Include
Ensuring Compliance | Reducing Risk | Navigating Regulatory Complexities
Life Sciences Compliance (FDA, EMA)
- Regulatory Submission Support: Ensure compliance with FDA, EMA, and other global regulatory requirements for documentation and reporting.
- GxP Compliance Solutions: Implement Good Practice (GxP) standards to maintain safety and integrity in pharmaceutical and biotech industries.
- Clinical Trial Compliance: Manage clinical trial documentation and data in compliance with global regulations, ensuring timely submissions and approvals.
ISO 9001 and 27001 Compliance
- Quality Management Systems: Develop and implement ISO 9001-compliant quality management systems (QMS) to ensure operational excellence.
- Information Security Management: Implement ISO 27001 standards to safeguard sensitive information and data.
- Certification Support: Prepare for ISO certification audits and maintain compliance with global industry standards.
Financial Services Regulatory Management
- Compliance with Financial Regulations: Ensure adherence to industry regulations such as PCI DSS, SOX, and AML (Anti-Money Laundering).
- Risk and Controls Assessment: Identify and manage risks related to financial compliance with tailored control mechanisms.
- Reporting Automation: Automate regulatory reporting processes to meet deadlines and reduce manual errors.
GxP Documentation Control
- Automated Document Workflows: Manage the creation, approval, and revision of GxP documents with automated workflows that reduce manual errors.
- Version Control and Audit Trails: Ensure that all regulatory documents are version-controlled and maintain complete audit trails for compliance.
- Secure Access: Protect sensitive GxP documents with secure access and permissions management.
Audit Preparation and Support
- Pre-Audit Assessments: Conduct thorough pre-audit reviews to identify gaps in compliance and address them before external audits.
- Audit Readiness Programs: Implement audit readiness programs to ensure your company is always prepared for regulatory inspections.
- Post-Audit Support: Provide ongoing support to resolve findings and implement corrective actions after an audit.
Stay Ahead of Regulatory Requirements with infoVish
Why Choose infoVish for IAM?
With infoVish’s Regulatory Compliance Management, your business can confidently navigate the regulatory landscape. With growing global regulations and stringent requirements from authorities like the FDA and GDPR, businesses must remain agile to keep up.
Expertise in Regulated Industries
With extensive experience in life sciences, financial services, and manufacturing, we understand the unique challenges you face.
Tailored Compliance Solutions
We customize our compliance management services to meet your specific regulatory needs, ensuring ongoing compliance and risk reduction.
Technology-Driven Compliance
We leverage the latest technologies in compliance monitoring and automation to ensure your business stays compliant with minimal manual effort.
Proactive Risk Management
Our approach to compliance is proactive, helping you identify and address risks before they become regulatory issues.
Comprehensive Support
From policy development to audit preparation, we provide end-to-end support for all your compliance needs.