Aqnix Research soultion

Our Experience:

With more than 5 years of focused experience in regulatory compliance, AQRegX delivers comprehensive regulatory support for sponsors and CROs across diverse therapeutic areas and study phases. Our team has successfully overseen 400+ regulatory initiatives, including pre-inspection readiness, regulatory query management, and compliance audits, ensuring trials meet local and global regulatory expectations.

AQRegX combines deep regulatory expertise, structured workflows, and technology-enabled tracking to help organizations maintain inspection readiness, data integrity, and process efficiency. By proactively addressing regulatory gaps and streamlining compliance activities, AQRegX transforms regulatory challenges into a strategic advantage for clinical programs.

Our Regulatory Compliance Services:

Pre-Inspection Readiness & Mock Audits

Assess sites and sponsor systems, identify compliance gaps, and prepare for regulatory inspections with mock assessments.

Regulatory Query Management

Track, respond to, and resolve queries from regulatory authorities efficiently, maintaining timelines and compliance standards.

Submission Tracking & Documentation Review

Oversee clinical trial submissions, supporting documents, and records to ensure completeness and accuracy.

Compliance Audits Across Sites and Vendors

Perform comprehensive audits to verify adherence to regulatory standards, SOPs, and internal quality systems.

Gap Analysis & Corrective Action Recommendations

Identify deficiencies in processes or documentation and provide actionable recommendations to prevent recurrence.

Risk-Based Compliance Monitoring

Prioritize oversight of high-risk processes or sites to proactively mitigate regulatory or operational issues.

SOP Review & Regulatory Advisory

Support organizations in reviewing and updating SOPs in line with current regulations and best practices.

Technology-Enabled Reporting & Dashboards

Provide sponsors and stakeholders with centralized access to compliance status, audit outcomes, and action plans.

Training & Guidance for Sponsors & Sites

Conduct workshops and guidance sessions to improve staff competency, compliance culture, and regulatory preparedness.

Continuous Regulatory Updates & Best Practices

Keep sponsors and sites informed of evolving local and global regulations, ensuring ongoing compliance.

Solution:

Pre-Inspection Readiness – Structured preparation, mock audits, and document review ensure sites and sponsors are inspection-ready.

Regulatory Query Management – Timely, accurate, and consistent response to queries from authorities or ethics committees.

Compliance Gap Analysis – Identify gaps in SOPs, processes, and documentation, and implement corrective actions.

Standardized Regulatory Workflows – Efficient submission tracking, document management, and reporting ensure consistency.

Regulatory Intelligence & Updates – Continuous monitoring of global and local regulatory changes to ensure compliance.

Document Review & Quality Assurance – Verification of submissions, essential documents, and correspondence for accuracy and completeness.

Training & Guidance – Educate site and sponsor teams on regulatory requirements, inspection preparation, and compliance best practices.

Technology-Enabled Oversight – Centralized dashboards, trackers, and reporting tools provide real-time visibility and audit readiness.

Risk-Based Compliance Strategies – Prioritize high-risk processes, sites, and documents to prevent findings and regulatory delays.

Continuous Improvement Recommendations – Provide actionable insights to strengthen regulatory operations and ongoing compliance.

Benefits of AQRegX Regulatory Compliance Services:

Inspection-Ready Sites & Sponsors – Continuous readiness ensures smooth regulatory audits and inspections.

Timely Regulatory Query Resolution – Quick and consistent responses minimize delays in approvals and submissions.

Improved Documentation Quality – Accurate, complete, and compliant regulatory records.

Reduced Compliance Risk – Proactive identification and mitigation of regulatory gaps prevent findings and trial delays.

Streamlined Processes & Efficiency – Standardized workflows and technology tools reduce effort, errors, and time.

Regulatory Confidence & Transparency – Sponsors gain clear visibility into compliance status across sites and systems.

Enhanced Investigator & Team Competency – Training ensures teams understand regulatory expectations and follow SOPs correctly.

Optimized Resource Allocation – Efficient assignment of compliance tasks reduces operational burden.

Actionable Insights for Continuous Improvement – Recommendations help improve regulatory operations for future trials.

Global & Local Regulatory Alignment – Ensure all trial activities comply with evolving international and national regulations.

Your Partner in Audit-Ready Compliance

Our Experience:

Our Regulatory Compliance Services:

Solution:

Benefits of AQRegX Regulatory Compliance Services: