Gap Analysis for Marketing Authorization Application (MAA) – EU (CP, DCP, MRP, National Procedures)

Regulatory Operations

eCTD Publishing and Submission Services

Expert Gap Analysis to Ensure Regulatory Compliance Across the European Union

Navigating the Marketing Authorization Application (MAA) process in the European Union requires strict adherence to complex regulatory frameworks, including EMA guidelines, national authority requirements, and the Common Technical Document (CTD) format. Whether you’re submitting through the Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), or a National Procedure, Techsol Life Sciences provides tailored Gap Analysis Services to ensure your MAA dossiers are complete, compliant, and submission-ready.

Our MAA Gap Analysis Approach Covers:

Evaluation Across All Application Routes

Centralized Procedure (CP): Ensures compliance with EMA/CHMP requirements, including Orphan Designation, Advanced Therapy Medicinal Product (ATMP) status, and centralized SmPC templates.
Decentralized (DCP) and Mutual Recognition (MRP) Procedures: Checks dossier consistency across Reference Member State (RMS) and Concerned Member States (CMS), ensuring national variations are adequately addressed.
National Procedures: Tailored gap reviews for local authority expectations, including country-specific language requirements and national module templates.

Module-by-Module Review (CTD Format)

Module 1: Checks for administrative completeness, local forms, declarations (QPPV, GMP), and Annex documents tailored for each EU country.
Module 2: Reviews overviews and summaries for scientific accuracy, consistency with full data, and adherence to current EMA guidelines.
Module 3: Evaluation of CMC data, including comparability studies, control strategies, validation, and stability testing.
Module 4 & 5: Assessment of nonclinical and clinical study data, bridging strategies, statistical analyses, and endpoint justifications.

Regulatory Alignment and Compliance Checks

Verification of alignment with EMA guidance documents, CMDh best practices, and ICH guidelines (Q8–Q12, M4, M8).
Identification of outdated references, missing justifications, and inconsistencies across modules.

Country-Specific Requirements

Detailed analysis of RMS and CMS-specific documentation preferences (e.g., local labeling formats, PIL readability testing reports, and mock-ups).
Assessment of national deviations from EU guidance and procedural expectations.

Identification of Gaps and Risk Assessment

Detection of missing data, incorrect document structure, or non-compliant formatting.
Highlighting potential regulatory objections and suggesting proactive solutions to mitigate delays.

Strategic Remediation Planning

Development of a targeted plan to close gaps before submission or during the clock-stop period.
Support in document updates, additional data generation, and preparation for Scientific Advice or Pre-Submission Meetings.

Techsol’s EU MAA Gap Analysis – Fast, Aligned, Submission-Ready

Techsol ensures your EU Marketing Authorisation Applications (MAAs) are fully compliant and submission-ready. Our experts identify gaps, align documentation with EMA, CMDh, and national requirements, and support CP, DCP, MRP, and National Procedures.