Gap Analysis for CTA & MAA - Techsol Life Sciences

Regulatory Operations

eCTD Publishing and Submission Services

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

Tailored Support for EU, Canada, and Global Regulatory Submissions

Understanding the regulatory requirements and documentation standards of each region is crucial when conducting clinical trials across countries. Regulatory gaps or inconsistencies can result in delays, rejections, or extra review cycles.

At Techsol Life Sciences, we provide comprehensive Clinical Trial Application (CTA) gap analysis and dossier compilation services. Our regulatory team carefully reviews your existing documentation to identify any missing gaps or non-compliant elements, aligns it with regional requirements, and prepares a fully compliant submission package.

Whether you’re targeting the US FDA, EMA, Health Canada, PMDA, or other regulatory authorities, we ensure your clinical trial dossiers are complete, consistent, and submission-ready.

EU Clinical Trial Application (CTA) under EU CTR 536/2014

After the implementation of the Clinical Trials Regulation (EU) 536/2014, the European Union has transitioned to a centralized submission system through the Clinical Trials Information System (CTIS), replacing the national submissions under 2001/20/EC.

Our approach for EU CTA Gap Analysis:

Part I & Part II Document Assessment:

Part I (evaluated jointly by all concerned Member States): Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure (IB), Clinical Trial Protocol, and safety data
Part II (evaluated nationally): Informed Consent Forms, subject recruitment materials, data protection compliance, and insurance documents

CTIS Portal Readiness:

Verification of documents for compatibility with CTIS requirements
Analysis of data and document versioning
Identification of discrepancies between uploaded content and system validation expectations

Ethics and Regulatory Synchronization:

Ensuring consistency between regulatory and ethics submissions under the new harmonized process

GCP and EU Guidance Alignment:

Compliance with EMA guidelines, Good Clinical Practice (ICH E6 R2), and EU-specific transparency rules (e.g., layperson summaries, public disclosures)

Remediation Recommendations:

Actionable strategies to address deficiencies, including missing risk assessments, outdated safety data, or unstructured protocol designs

CTA Gap Analysis: Health Canada

In Canada, CTAs must adhere to Health Canada’s Food and Drug Regulations and guidance documents, such as GUI-0100 and ICH E6.

Health Canada CTA Gap Analysis Covers:

CTA Gap Analysis for Other Global Regions

We provide region-specific CTA gap assessments for:

Key Gap Analysis Elements for Global CTAs Include:

Area of Focus	Description
Protocol Review	Design consistency, inclusion/exclusion criteria, endpoints, safety plan
Investigator’s Brochure (IB)	Consistency with preclinical/clinical data and product safety profiles
IMPD / Product Information	Adequacy of CMC, pharmacology, toxicology data across jurisdictions
Patient-Facing Documents	Gap check of Informed Consent Forms, diaries, and lay summaries
Ethics & Regulatory Submissions	Readiness for concurrent or sequential review processes
Transparency Compliance (EU Only)	Review of redaction strategy, public disclosures, and layperson summaries
Labeling & Packaging (Investigational)	Adequacy of label content, translation needs, and region-specific templates
Insurance & Indemnification Docs	National conformity and completeness of indemnity documentation

Benefits of Techsol’s CTA Gap Analysis 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.