At eCTD Pharma, we specialize in the meticulous preparation of Module 1 documents, ensuring they meet the stringent requirements of global regulatory authorities, including FDA, EMA, MHRA, Health Canada, Swissmedic, and ROW markets.

As the gateway to a successful eCTD submission, Module 1 plays a critical role in regulatory acceptance. Poorly structured or non-compliant documents can lead to costly delays, rejections, and additional queries from health authorities. Our expertise in cover letters, application forms (EAF), and administrative documents ensures a seamless submission process for your regulatory filings.

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Regulatory-Compliant Cover Letters

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A well-structured cover letter is essential for directing regulatory agencies to the correct information within your submission. Our team ensures that:

• Each cover letter is tailored to the specific regulatory authority (FDA, EMA, MHRA, etc.)

• It includes all mandatory elements and references to relevant guidance

• It clearly communicates the purpose of the submission and any regulatory considerations

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Electronic Application Forms (EAF) – Precision & Accuracy

 

The EAF (Electronic Application Form) is a vital component of an eCTD submission. Errors or inconsistencies in the form can result in technical validation failures and unnecessary health authority queries. We ensure:

• Accurate data entry and cross-checking to prevent discrepancies

• Full compliance with the latest regulatory form requirements (eAF for EMA, FDA 356h form, MHRA national application forms, etc.)

• Flawless validation and testing before final submission

 

Other Key Module 1 Documents We Handle

 

Beyond cover letters and EAFs, we provide expert preparation for:

• Letters of Authorization (LOA)

• Administrative and procedural documents

• Agency-specific declarations and annexes

• Power of Attorney (POA) documents

• Responses to regulatory queries

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Why Choose eCTD Pharma for Module 1 Document Creation?

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• Extensive Regulatory Knowledge – Our team stays updated with the latest global regulatory authority requirements, ensuring compliance for every submission.

• Attention to Detail – We meticulously review every document, ensuring accuracy and completeness before submission.

• Tailored Solutions – Whether it's an initial submission, variation, or renewal, we customize our approach to meet your specific needs.

• Error-Free Submissions – Our expertise minimizes errors, reducing the risk of rejection and accelerating regulatory approval timelines.

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Partner with eCTD Pharma for Seamless Submissions

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A flawless Module 1 submission is the foundation of a successful regulatory approval. Let eCTD Pharma take the burden off your shoulders with our expert document preparation services.

Contact us today to ensure your next submission is compliant, efficient, and successful.