At eCTD Pharma, we provide comprehensive eCTD life cycle management services, ensuring that your regulatory submissions remain compliant, up to date, and seamlessly maintained throughout their entire life cycle. With our in-house publishing software, we also offer a secure submission storage solution, giving you complete control over your regulatory records while ensuring effortless access for future updates.

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Why eCTD Life Cycle Management Matters

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Regulatory submissions don’t end once they are approved. Health authorities like the FDA, EMA, MHRA, and Health Canada require continuous updates, modifications, and compliance-driven changes. A well-managed eCTD life cycle ensures that:

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• Your submissions remain fully compliant with evolving regulations

• Variations, amendments, and annual reports are efficiently handled

• Data remains organized and accessible for future updates

• Errors and inconsistencies are minimized, reducing regulatory queries

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At eCTD Pharma, we manage all aspects of your submission’s life cycle, allowing you to focus on bringing innovative products to market while we handle compliance and regulatory maintenance.

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Our eCTD Life Cycle Services

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Our expert team provides ongoing submission management, including:

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• Variations & Amendments – Submitting post-approval changes, including CMC updates, safety updates, and administrative modifications.

• Annual Reports & Renewals – Ensuring timely submissions of required regulatory reports.

• Responses to Health Authority Queries – Addressing deficiencies and regulatory requests promptly to avoid approval delays.

• Post-Marketing Changes – Managing updates related to safety reporting, labeling revisions, and product modifications.

• Efficient Re-submissions & Replacements – Handling document replacements and resubmissions with 100% accuracy.

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Secure Submission Storage on Our In-House Publishing Software

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Managing eCTD submissions requires secure, reliable storage. At eCTD Pharma, we offer submission storage solutions through our in-house publishing software, allowing clients to:

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• Securely store, track, and manage their regulatory dossiers

• Easily retrieve previous submissions for ongoing updates

• Ensure full regulatory compliance with a structured document management system

• Streamline life cycle updates with direct access to previously submitted dossiers

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With secure, cloud-based accessibility and full compliance with global regulatory guidelines, our storage solution provides a seamless way to protect, maintain, and manage your regulatory submissions.

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Why Choose eCTD Pharma for Life Cycle Management & Storage?

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• Expert Regulatory Oversight – Our team ensures your submissions remain compliant throughout their life cycle.

• Seamless Updates & Modifications – We handle every regulatory change efficiently and accurately.

• Secure & Accessible Submission Storage – Our in-house publishing software gives you full control over your regulatory records.

• Minimized Regulatory Risk – Avoid errors, inconsistencies, and compliance gaps with our expert support.

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Ensure Your Submissions Stay Compliant & Secure with eCTD Pharma

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Managing regulatory submissions doesn’t stop after approval. Let eCTD Pharma handle your eCTD life cycle updates and provide secure submission storage, ensuring your regulatory success.

 

Contact us today to learn more about our life cycle management and storage solutions!