At eCTD Pharma, we offer direct electronic submission services via the official health authority portals for FDA, EMA, and MHRA. By submitting applications directly through these secure platforms, we ensure a swift, compliant, and seamless regulatory approval process, reducing delays and expediting market access for your pharmaceutical products.

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Why Direct Submissions Matter

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Regulatory agencies have strict requirements for how electronic submissions are received and processed. Submitting through the appropriate health authority portal ensures:

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• Faster Processing Times – Direct uploads eliminate the need for third-party intermediaries, reducing turnaround time.

• Enhanced Compliance – Health authorities receive submissions in their required format, minimizing the risk of technical rejections.

• Secure & Confidential Transfers – Your sensitive data is transmitted via fully encrypted, government-regulated portals.

• Real-Time Tracking & Updates – Immediate submission confirmations and status tracking for greater transparency.

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Our Direct Submission Capabilities

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At eCTD Pharma, we have extensive expertise in handling direct electronic submissions through the following portals:

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FDA – Electronic Submissions Gateway (ESG):

• Fast and compliant electronic submissions for IND, NDA, ANDA, BLA, DMF, and post-marketing reports

• Secure transfer of submission data, reducing processing times

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EMA – eSubmission Gateway & Web Client:

• Direct uploads for MAA, Variations, Renewals, and Clinical Trial Applications (CTA)

• Fully compliant with EU eCTD specifications

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MHRA – MHRA Submissions Portal:

• Seamless submission of UK marketing authorizations, post-Brexit updates, and variations

• Advantage of UK-Based Expertise: As a UK-based eCTD submission consultancy, we ensure full compliance with MHRA’s evolving regulatory requirements

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Why Choose eCTD Pharma for Direct Submissions?

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• Regulatory Expertise – Decades of experience in handling FDA, EMA, and MHRA submissions with 100% compliance.

• Error-Free, First-Time Submission Success – Avoid delays by ensuring that your dossier is submission-ready before upload.

• Faster Approvals – Direct access to health authority portals speeds up processing and minimizes back-and-forth communications.

• End-to-End Submission Management – From document preparation to successful acceptance, we handle every step of the process.

• Global Reach, Local Knowledge – Our expertise covers multiple international markets, ensuring that your submission meets regional requirements.

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Get Your Submissions Approved Faster with eCTD Pharma

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By leveraging our direct submission services, you can ensure your regulatory applications reach the right authority quickly, securely, and in full compliance. Our team of experts ensures a smooth submission process so you can focus on bringing your products to market faster.

 

Contact us today to submit your next application directly via the appropriate health authority portal!