Global Regulatory Dossier Gap Analysis Services

Regulatory Operations

Ensuring Regulatory Compliance and Submission Readiness with Confidence

At Techsol Life Sciences, we understand that a well-structured and compliant regulatory dossier is the foundation of successful health authority submissions. With the ever-evolving global regulatory landscape, even the smallest content gaps, inconsistencies, or misalignments can delay product approvals or lead to avoidable deficiency letters. That’s why our Global Regulatory Dossier Gap Analysis Services are designed to provide a meticulous, module-wise evaluation of your submission dossiers ensuring completeness, technical accuracy, and regulatory compliance for global health authority submissions.

Whether you’re preparing an Investigational New Drug (IND) application for the U.S. FDA, a New Drug Application (NDA), a Biologics License Application (BLA), an Abbreviated New Drug Application (ANDA), or a Clinical Trial/Marketing Authorization Application (CTA/MAA) for global markets including the EU and Canada, our gap analysis services are tailored to reduce regulatory risk and improve submission readiness.

Regulatory Dossier Gap Analysis?

A regulatory dossier gap analysis is a systematic review process used to assess the completeness and conformance of the existing technical documentation with the applicable regulatory requirements, standards, ICH guidelines, and market-specific expectations. It allows sponsors to identify data or documentation gaps before submission, reducing the likelihood of rejection or review delays.

At Techsol, we take a varied approach to assess both content and format of the dossier and identifying potential deficiencies and offering services or recommendations for remediation.

Gap Analysis Services

Our team of regulatory professionals performs detailed, submission-type-specific gap analyses across the following application types:

Investigational New Drug (IND) – U.S. FDA

We review and assess IND dossiers to ensure they are ready for clinical trial initiation in the U.S.:

Evaluation of preclinical study summaries, clinical trial protocols, and manufacturing data in Modules 1–5
Review for alignment with FDA guidance, including Pre-IND Meeting Readiness
Assessment of investigator brochures (IB), toxicology data, and safety pharmacology
Recommendations for missing or inconsistent data to avoid clinical hold issues

New Drug Application (NDA) –
U.S. FDA

For NDA submissions, we provide a comprehensive dossier assessment to ensure:

Adequate presentation of CMC, clinical, and nonclinical modules
Review of risk management plans (RMPs), REMS, and labeling
Evaluation of FDA guidance adherence (e.g., formatting per eCTD specifications)
Cross-checking of data integrity between summary documents and full reports

Abbreviated New Drug Application (ANDA) – U.S. FDA

For generic drug submissions, our analysis focuses on:

Bioequivalence study documentation and statistical validation
In-vitro dissolution data and product-specific guideline conformity
Completeness of DMF references, QbD elements, and excipient justifications
GDUFA alignment and module cross-referencing

Biologics License Application (BLA) - U.S. FDA

Biologic product submissions require in-depth gap assessments:

Comparability studies, immunogenicity risk assessments, and analytical method validations
Conformance to 21 CFR Part 600 requirements
Evaluation of manufacturing processes, quality controls, and biosimilarity data
Identification of data that may raise questions during advisory committee or inspection review

Key Elements of Our Gap Analysis Approach

We conduct an in-depth, multi-layered analysis covering all modules of the eCTD format:

1. Module-wise Review (Modules 1–5)

Administrative documents, forms, and regional information (Module 1)
Summaries of quality, clinical, and nonclinical data (Module 2)
Chemistry, Manufacturing, and Controls (CMC) data (Module 3)
Nonclinical pharmacology/toxicology and safety studies (Module 4)
Clinical study reports, trial data, statistical analyses (Module 5)

2. Regulatory Conformance Check

Assessment against current FDA, EMA, Health Canada, PMDA, TGA, and WHO requirements
Identification of outdated formats, obsolete guidance references, or inconsistent documentation

3. ICH and Regional Guidelines Alignment

Ensuring compliance with ICH M4, M8 (eCTD), and Q8–Q12 series for quality risk management, development, and lifecycle considerations

4. Deficiency Risk Assessment

Detection of incomplete or poorly justified data
Identification of gaps that could trigger a major objection or query from regulatory reviewers

5. Remediation Planning

Customized strategies to fill identified gaps
Recommendations on data generation, justification letters, bridging strategies, or scientific advice meetings

Advantages of Selecting Techsol's Services for Gap Analysis

Faster Submission Readiness: Sponsors can proactively address issues, accelerating the regulatory timeline.
Minimized Regulatory Risk: Reduced chance of receiving Refuse-to-File (RTF) letters, 483s, or deficiency queries.
Global Harmonization: Ensures consistent content across submissions to multiple markets.
Supports Lifecycle Management: Facilitates smooth variations, renewals, and post-approval changes.
Strategic Planning: Allows for prioritization of critical data generation and informed decision-making for go/no-go milestones.