At eCTD Pharma, we take a meticulous approach to Regulatory Gap Analysis, ensuring that your submission dossiers meet all health authority requirements with precision. Our expertise allows us to identify potential compliance risks before submission, helping companies avoid delays, additional information requests, and potential rejection. With years of experience navigating FDA, EMA, MHRA, Health Canada, Swissmedic, and other global regulatory frameworks, we ensure your submission is aligned with the latest standards.

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How We Perform Regulatory Gap Analysis

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Our Regulatory Gap Analysis process begins with an in-depth review of your existing documentation. We analyze the structure, content, and formatting against the most up-to-date regulatory requirements, identifying any discrepancies that could impact approval.

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We assess whether all required sections are present and formatted correctly, ensuring that each document meets the expectations of the target regulatory agency. Our team carefully reviews technical elements such as hyperlinks, bookmarks, metadata, and dossier structure to verify compliance with eCTD specifications. In addition, we evaluate the scientific content for consistency, clarity, and adherence to submission guidelines, highlighting any areas that may need revision or supplementation.

Once our assessment is complete, we provide a detailed report outlining any deficiencies, risks, and areas for improvement. This report includes clear recommendations on how to address each issue, ensuring that your submission is fully optimized for regulatory review. If necessary, we can also assist with document remediation, helping you revise, format, and structure your submission for the best possible outcome.

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Why Choose eCTD Pharma for Gap Analysis?

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With deep industry expertise and a proven track record of successful submissions, eCTD Pharma ensures that your regulatory dossiers are comprehensive, technically sound, and ready for submission. Our proactive approach helps minimize risks, reduce costly delays, and improve approval timelines. We don’t just identify issues—we help you resolve them efficiently, so your submission moves forward smoothly and successfully.

 

Contact us today to ensure your submission is fully compliant and ready for regulatory review!