CMC HealthChek™ – Comprehensive Gap Analysis for Regulatory Compliance
Proactive Risk Assessment & Compliance Strategy for Drug Development
Navigating pharmaceutical development is challenging, with complex regulatory requirements and heightened scrutiny from health authorities. DSI’s CMC HealthChek™ provides a structured, risk-based gap analysis that accelerates compliance and fast-tracks your next regulatory milestone.
DSI CMC HealthChek™ is a comprehensive due diligence solution for sponsors seeking to proactively address development and compliance risks. Our methodical approach evaluates CMC documentation, identifies gaps, and proposes feasible remediation strategies—all in an eCTD format to streamline regulatory submissions.
Comprehensive CMC Gap Analysis & Risk Assessment
Tailored Compliance Solutions for Every Stage of Development
- Phase-Appropriate Risk Identification: Our assessment aligns with your product’s current stage, whether in early-phase development, clinical trials, or pre-market authorization.
- Regulatory Submission Readiness: We ensure data completeness for INDs, NDAs, CTDs, and EU submissions, identifying potential roadblocks early.
- Manufacturing & Quality Systems Review: Our experts analyze drug substance (DS), drug product (DP), and quality systems (QMS) to ensure compliance and efficiency.
- eCTD-Based Documentation Assessment: We provide a structured overview of CMC gaps in an eCTD format, making it easy to integrate findings into submission dossiers.
What We Review
- Documentation from Labs, Vendors & Manufacturing Sites: Ensuring accuracy and completeness across development reports, stability data, validation protocols, and regulatory correspondence.
- CMC Data Package Evaluation: Identifying missing, outdated, or non-compliant documentation that may hinder approval.
- Regulatory Meeting Readiness: Preparing for EOP2 (End-of-Phase 2) meetings, pre-NDA/MAA discussions, and agency interactions.
Remediation Strategies & Compliance Roadmap
Addressing CMC Deficiencies Before They Impact Timelines
Our gap analysis reports categorize findings into minor, major, and critical risks, along with tailored remediation plans. We help mitigate potential delays by recommending:
- CMC strategy refinements to enhance compliance with FDA, EMA, and ICH guidelines.
- Validation and stability study optimization to ensure robustness of manufacturing processes.
- Pre-submission risk mitigation to avoid regulatory queries and additional agency review cycles.
Key Areas of Impact
- Design & Formulation Optimization: Ensuring that process design meets regulatory and commercial viability standards.
- Site Inspection & Monitoring Support: Readiness assessments for GMP audits, vendor qualifications, and manufacturing site inspections.
- Regulatory-Focused Remediation Approaches: Gap closure plans that align with ICH, FDA, EMA, and global health authority requirements.
Why Choose CMC HealthChek™?
Strategic Advantage in Regulatory Compliance & Market Readiness
- Early Identification of Compliance Risks: Avoid costly delays by addressing CMC gaps before submission.
- Streamlined Regulatory Interactions: Prepare robust documentation for IND, NDA, and BLA filings.
- Reduced Development Costs & Time-to-Market: Proactive risk mitigation improves regulatory approval timelines and budget efficiency.
- Expert-Driven Insights & Tailored Solutions: Leverage DSI’s multidisciplinary team of regulatory, manufacturing, and quality experts for customized compliance strategies.
DSI Expertise in CMC Lifecycle Management
At DSI, we integrate decades of CMC, regulatory, and manufacturing experience to provide unparalleled development and commercialization support. Our CMC HealthChek™ methodology consolidates risk-based submission writing, compliance strategy, and regulatory intelligence across small molecules, biologics, and advanced therapies.
Unlike traditional compliance solutions that require significant investment in time and resources, DSI’s CMC HealthChek™ accelerates the process through best practices, automation, and regulatory foresight.
Let’s Talk – Empower Your CMC Strategy with DSI
Ensure regulatory readiness and streamlined development with DSI’s expert CMC consulting. Contact us today to learn how CMC HealthChek™ can help you achieve compliance success and faster time-to-market.