At eCTD Pharma, we specialize in managing and executing pharmaceutical regulatory submissions with precision and efficiency. Whether you're filing with the FDA, EMA, MHRA, Health Canada, Swissmedic, or other regulatory authorities, we ensure that every submission meets the latest regulatory standards and formatting requirements. Our expertise covers a wide range of pharmaceutical submissions, from initial applications to lifecycle management, ensuring your products remain compliant throughout their market life.

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What Are Pharmaceutical Submissions?

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Pharmaceutical submissions are the official regulatory filings required to gain approval for a new drug, biologic, or medical product. These submissions contain critical scientific, technical, and administrative data that regulatory agencies use to assess the safety, efficacy, and quality of a product. Submissions follow strict guidelines based on the eCTD (Electronic Common Technical Document) format, which standardizes the dossier structure across global agencies.

The process involves preparing and submitting various modules of information, including preclinical and clinical trial data, manufacturing details, safety reports, and post-marketing updates. Each submission must adhere to specific agency requirements, making expert guidance essential to avoid delays and ensure a smooth approval process.

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How We Handle Pharmaceutical Submissions

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At eCTD Pharma, we provide a comprehensive, end-to-end submission service, handling everything from dossier preparation to electronic publishing and final submission. Our approach ensures a seamless regulatory process, reducing the risk of queries, refusals, or compliance issues.

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Our submission process begins with an initial assessment of your data and documents to confirm completeness and regulatory compliance. We assist in compiling and structuring the submission in accordance with ICH eCTD guidelines, ensuring all documents are properly formatted, hyperlinked, bookmarked, and validated. Once the dossier is finalized, we use state-of-the-art publishing software to convert it into an eCTD-compliant format and perform rigorous validation checks to confirm adherence to global agency requirements.

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After validation, we securely submit the dossier through the appropriate regulatory authority portals, such as the FDA ESG, EMA CESP, or MHRA portals, ensuring timely and efficient delivery. Post-submission, we provide ongoing support, including responding to agency queries, making amendments, and managing lifecycle updates to keep your submission compliant throughout its approval journey.

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Why Choose eCTD Pharma for Your Pharmaceutical Submissions?

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With years of experience in regulatory submissions, eCTD Pharma brings a deep understanding of global requirements and a commitment to accuracy and efficiency. Our team of regulatory professionals ensures that your submission is compliant, complete, and strategically positioned for a successful outcome. Whether you're submitting an IND, NDA, BLA, MAA, ANDA, or DMF, we have the expertise to support your regulatory journey from start to finish.

 

Contact us today to streamline your pharmaceutical submissions and accelerate your regulatory approvals!