Expert, Submission-Ready Solutions That Regulatory Authorities Trust
At Indivirtus Healthcare Services, our comprehensive Regulatory Support services deliver expertly crafted documentation that meets the exacting standards of global health authorities. From detailed SMEPAC reports to complete CTD/eCTD modules, we ensure your regulatory submissions are thorough, compliant, and inspection-ready.
Our Regulatory Support service delivers comprehensive documentation solutions specifically designed for pharmaceutical manufacturers. We cover everything from containment performance reports to complete CTD/eCTD module preparation, all aligned with global regulatory standards for seamless submissions.
Precise, compliant documentation is the foundation of successful regulatory approval and market access. Our expert services eliminate the risk of delays, rejections, or compliance issues by ensuring your submissions exceed the expectations of FDA, EMA, PMDA, and other global authorities.
Indivirtus Healthcare Services serves as your dedicated regulatory partner, leveraging our team of former regulatory professionals and industry specialists to deliver submission-ready documentation that stands up to scrutiny. We provide customized solutions, comprehensive gap analysis, and complete inspection readiness support.
At Indivirtus Healthcare Services, we blend extensive regulatory expertise with a client-focused approach to deliver documentation that consistently meets the highest global standards. Our comprehensive process begins with a deep dive into your specific product requirements and regulatory objectives, followed by the creation of fully customized documentation packages. We excel in developing SMEPAC-compliant containment reports with advanced 3D visualization, comprehensive ICH Q9-based risk assessments (FMEA, HACCP, PHA), and detailed cleaning validation master files with scientifically justified health-based exposure limits (HBEL).
For regulatory submissions, we expertly prepare complete CTD/eCTD modules for ANDA, DMF, and MA applications, ensuring perfect alignment with the specific requirements of FDA, EMA, PMDA, and other global authorities. Our experienced team conducts thorough gap analysis against evolving standards like EU GMP Annex 1 (2022) to proactively identify and address potential compliance challenges. During regulatory inspections, we provide comprehensive support through detailed position papers, strategic response plans, and realistic mock audits, ensuring your team is completely prepared and confident for regulatory scrutiny.
SMEPAC-Compliant Containment Documentation: Comprehensive reports featuring advanced 3D visualization for complete regulatory compliance.
Expert Risk Assessment Dossiers: Professional FMEA, HACCP, and PHA-based assessments for robust quality assurance.
Complete Cleaning Validation Master File: Scientifically justified HBEL documentation for all cleaning processes.
Professional CTD Modules: Complete Quality and Nonclinical modules for ANDA, DMF, and MA submissions.
Strategic Regulatory Gap Analysis: Actionable compliance roadmap with clear steps to address any deficiencies.
Comprehensive Inspection Readiness Package: Detailed Q&A documents and realistic mock audits for complete regulatory preparation.
Expert eCTD Publishing Support: Professional assistance for seamless electronic submission processes.
Our Regulatory Support services are meticulously designed to exceed the demanding standards of global health authorities, ensuring your documentation is comprehensive, compliant, and audit-ready. By aligning with industry-leading guidelines and best practices, we deliver scientifically sound documentation that confidently withstands the most rigorous scrutiny from regulatory bodies, giving you complete confidence in your submissions and inspection preparedness.
Our expert Regulatory Support services are specifically designed for pharmaceutical manufacturers preparing for critical regulatory submissions, inspections, or global market expansions. Key applications include developing comprehensive CTD modules for ANDA or DMF filings, validating advanced containment systems for potent compounds, and ensuring full compliance with evolving standards like EU GMP Annex 1. Our services successfully support new product launches, effectively address regulatory deficiencies, and thoroughly prepare manufacturing facilities for inspections by global authorities, consistently ensuring regulatory success and market access.
Indivirtus Healthcare Services delivers unmatched expertise through our exceptional team of former regulatory professionals, certified toxicologists, and seasoned industry specialists, ensuring your documentation is scientifically robust and globally compliant. We prioritize rapid turnaround times while maintaining strict confidentiality protocols to protect your valuable proprietary data, delivering submission-ready packages without ever compromising on quality or thoroughness. Partner with us to confidently navigate complex regulatory landscapes, achieve complete regulatory compliance, and secure successful market access with absolute confidence.
We use a proven 'universal core dossier' approach that starts with creating comprehensive foundational content meeting the most stringent requirements (typically EMA standards), then we add specific modules tailored to each agency's unique expectations. For example, we enhance FDA submissions with detailed SMEPAC data presentation while adding comprehensive HBEL justification for EMA requirements.
For advanced therapies, we take a tailored approach: 1) We develop product-specific risk frameworks that go beyond standard ICH Q9 guidelines, 2) We create innovative containment strategies that blend pharmaceutical GMP with specialized biosafety principles, and 3) We prepare comprehensive regulatory interaction packages that help educate reviewers on unique control approaches for these novel therapies.
Absolutely! We specialize in deficiency response with a proven track record: 1) We conduct rapid, thorough gap analysis of deficiency letters, 2) We prepare scientifically robust response packages with comprehensive supporting data, and 3) We provide mock oral explanation rehearsals. Our approach has achieved over 85% first-round resolution success for containment-related regulatory queries.
We maintain a comprehensive global SMEPAC database that tracks regional preferences: 1) FDA's focus on detailed operator exposure data, 2) EMA's preference for thorough cross-contamination risk analysis, and 3) PMDA's unique regulatory requirements. We create modular reports where region-specific sections seamlessly integrate with a robust core dataset, ensuring complete compliance across all markets.
Our complete inspection readiness package includes: 1) Detailed anticipated Q&A documents with comprehensive scientific references, 2) Realistic mock audit simulations specifically focused on containment and cleaning validation, 3) Targeted staff training on efficient documentation retrieval and presentation, and 4) Professional visual aids designed to help explain complex containment strategies clearly to regulatory inspectors.
Our complete service package includes SMEPAC-compliant containment reports with 3D visualization, comprehensive ICH Q9-based risk assessments, thorough cleaning validation master files, complete CTD/eCTD modules for all submission types, detailed gap analysis against current standards, comprehensive inspection readiness packages, and professional eCTD publishing support.
We ensure complete compliance with all major global health authorities including FDA, EMA, PMDA, Health Canada, TGA, and others. Our documentation strictly adheres to internationally recognized standards like ICH Q9, EU GMP Annex 1 (2022), WHO TRS 992, and region-specific guidelines to ensure global acceptance.
We provide comprehensive inspection readiness through detailed Q&A documents, realistic mock audits conducted by former regulatory professionals, and strategic response planning. Our thorough gap analysis against current standards like EU Annex 1 (2022) ensures complete compliance and builds confidence for any regulatory inspection.
We provide expert support for all major submission types including ANDA (Abbreviated New Drug Applications), DMF (Drug Master Files), and MA (Marketing Authorization) submissions. We prepare complete CTD/eCTD modules including Quality and Nonclinical sections, all tailored to meet specific global regulatory requirements.
We maintain the highest standards of confidentiality through comprehensive data protection protocols, strict access controls, and industry-leading security measures. All team members sign detailed confidentiality agreements, and we follow pharmaceutical industry best practices to completely safeguard your valuable proprietary data throughout every stage of the documentation and submission process.
Our services are most valuable when preparing for critical regulatory submissions, addressing compliance gaps identified during internal or external audits, validating containment systems for potent or novel compounds, preparing for scheduled regulatory inspections, or when expanding into new global markets with different regulatory requirements.