Gap Analysis
Identify and bridge compliance gaps in your CMC, clinical data, and dossiers.
Bridge Compliance Gaps for Successful Market Approval
Regulatory standards are constantly evolving. A dossier that was acceptable two years ago might face instant rejection today. At ADMFES, we offer highly detailed gap analysis services to identify missing details, obsolete guidelines, and inconsistent documentation. We are widely recognized as the best provider for gap analysis services, mapping your data files against national and international regulatory expectations.
Our team compares your CMC data, stability studies, impurity profiles, clinical trial validations, and bioequivalence data against target health authority directives. We deliver a detailed gap report along with actionable, step-by-step remediation plans.
The Best Provider for Gap Analysis
Our analysts crosscheck every CTD block, translating complex guidelines into specific list actions to safeguard your filings.
Our Gap Analysis & Remediation Scope
We specialize in identifying technical, clinical, and administrative gaps across product portfolios:
CMC Data Assessment
Review validation protocols, formulation files, and stability data reports against ICH guidelines.
Pre-Clinical & Clinical Review
Audit bioequivalence study protocols, pharmacological files, and clinical reports.
Labeling & Package Leaflet Audits
Check PIL (Patient Information Leaflets), SmPC, and packaging layouts for regional compliance.
Regulatory Upgrade Strategy
Identify upgrades needed to transition product dossiers from regional formats to ICH eCTD files.
Bridge Content Discrepancies Early
Rather than waiting for a regulatory query that suspends your approval process, our gap analysis detects inconsistencies beforehand. Our reports list missing items explicitly, matching sections directly to standard ICH guidelines for complete compliance.
Dossier Gap Analysis
Upload your dossier parameters to launch an expert gap audit.
Regulatory Services
- Regulatory Consulting
- Dossier Preparation & Compilation
- Due Diligence (Pre assessment)
- Gap Analysis
- Health Authority Communication
- Marketing Authorisation (MAA)
- FSSAI & Cosmetic Registration
- Medical Device Registration
- CDSCO India Registration
- Import License Application
- Indian Authorised Agent (IAA)