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Platform Highlights

Juphera is the first AI-driven platform focused exclusively on CTD Module 3 for generic drug submissions — transforming how both regulatory authorities and pharmaceutical companies manage, review, and validate dossiers.

Upload

Submit your structured CTD Module 3 dossier in PDF format.

Analyze

Our AI identifies and interprets technical sections using NLP — including formulation, control, and analytical data.

Validate

Juphera flags inconsistencies, missing info, and compliance gaps — tailored to the selected regulatory body.

Report

Get a clear, organized validation report with risk flags and improvement suggestions.

Juphera FAQ

What problem does Juphera solve?

Reviewing CTD Module 3 submissions for generic drugs is slow, manual, and error-prone. This leads to:

❌ Repeated submission errors
⏳ Delayed market access
😓 Overworked review teams

How does Juphera solve the problem of slow, error-prone CTD reviews?

How does Juphera solve the problem of slow, error-prone CTD reviews?
Juphera uses AI-powered validation to analyze, validate, and assess dossiers. By applying NLP (Natural Language Processing) and ML (Machine Learning), it ensures:

Faster, more consistent reviews
Higher-quality submissions
Reduced errors and rejections

Juphera is trained on ICH guidelines, Saudi FDA guidelines, and real approved dossiers — including actual inquiries, comments, and deficiencies that historically delayed approvals. This ensures Juphera reflects real-world regulatory practice, not just theory, helping both reviewers and pharma companies avoid repeating past mistakes.

Why focus on CTD Module 3 (Quality)?

Because it’s the most technical, complex, and error-prone part of the dossier. More than 70% of rejections and delays stem from Module 3. Juphera ensures these critical details are right from the start

Does Juphera replace human reviewers?

No. Juphera is a supportive AI assistant. It doesn’t replace experts — it augments them, making their work faster, more accurate, and less stressful. Final approval decisions remain with human reviewers.

How is Juphera different from current dossier submission systems?

Current electronic systems (e.g., Extedo, Lorenz) mainly act as gateways for dossier submission. They ensure files are uploaded in the correct format, but they do not validate the scientific or technical content.

Juphera, by contrast, acts as an AI technical reviewer. It:

Validates content against ICH and local guidelines
Learns from real approved dossiers
Integrates actual inquiries, comments, and deficiencies raised by authorities

This ensures each authority-specific version of Juphera is built on real regulatory experience, not just broad documentation rules.

Is Juphera compliant with regulatory standards?

Currently, Juphera is being trained primarily on:

📘 ICH M4Q guidelines (global reference)
🏛 Saudi FDA guidelines (the first targeted market)
✅ Actual Saudi FDA-approved dossiers, including full inquiry/response histories

Each drug authority will eventually have its own version of Juphera, customized to reflect its unique practices, comments, and requirements.

How does Juphera get access to real data and actual inquiries?

Through cooperation with supportive pharma companies (early clients) who share:

Their approved CTD dossiers
All authority inquiries, comments, responses, and variations leading to final approval

This collaboration allows Juphera to train on real regulatory experience. 👉 If you are a pharma company and want to cooperate with us, click here to get early access to Juphera with great discounts — a true win–win partnership.

How secure is Juphera?

Juphera is currently in the MVP and training phase, where we rely on third-party AI infrastructure to minimize costs. This is only for the development stage.

When Juphera is launched for real-world use:

📌 No client dossiers will ever be shared with third parties.
📌 We will never save or keep any company’s CTD files without explicit agreement.
📌 Pharma companies who choose to cooperate with us for training will do so under a clear consent model, knowing their documents are used only to enhance Juphera’s accuracy.

This ensures full data security and transparency for pharma companies and regulatory authorities.

Is Juphera considered an alternative to current dossier submission systems (e.g., Extedo, Lorenz)?

No. Juphera does not replace submission gateways or provide any official regulatory submission pathway.

Instead, Juphera is an AI technical reviewer that:

Helps regulatory authorities review dossiers faster, more accurately, and with higher quality
Helps pharma companies spotlight dossier content that could delay approval, based on historical data and authority standards

In short, Juphera works alongside submission systems — not in competition with them

How does Juphera benefit regulatory authorities?

Speeds up dossier reviews (months → weeks → days)
Strengthens regulatory oversight
Improves public health by accelerating access to affordable medicines

How long does it take to implement Juphera?

Juphera is currently in the MVP and training phase. Once training is completed, implementation will be easy and seamless. Authorities can integrate it into their workflow with minimal training.

How does Juphera ensure alignment with our authority’s specific requirements?

Juphera is trained not just on published guidelines, but also on:
- Real approved dossiers from your authority
- Actual past inquiries, comments, and common deficiencies
This ensures reviewers can identify recurring issues quickly, and pharma companies can avoid repeating the same mistakes.
👉 Juphera is currently under training for Saudi FDA standards. If you are a drug authority and want to be the next authority Juphera is trained on, [click here] to start the discussion.

How could Juphera reduce the CTD dossier review from 12 months to 10 days?

The 12-month cycle of dossier approval is mainly caused by repeated back-and-forth between pharma companies and drug authorities over missing data, outdated content, or unaligned requirements.
Juphera breaks this cycle by creating alignment from day one:
- 📌 Pharma companies using Juphera before submission → Their dossiers are pre-reviewed as per the latest requirements of the target drug authority.
- 📌 Drug authorities using Juphera in their review process → They receive dossiers already checked against their most recent standards.
This means:
- Authorities are reviewing dossiers that already meet their updated requirements.
- Pharma companies are notified in real time whenever new standards or requirements are published. Their teams can adjust dossiers immediately, ensuring compliance even before submission.
By keeping both sides aligned — pharma submission readiness + authority fast review — Juphera streamlines the long CTD review story into a short, smart, and efficient approval journey.

How does Juphera benefit pharma companies?

Pharma companies often lose valuable opportunities because of registration delays. Every delay means:
- 🚫 Lost market entry windows
- 💰 Significant revenue loss
- 📉 Increased costs from repeated submissions and longer holding times
Juphera changes this by:
- Ensuring dossiers are submission-ready from the start
- Highlighting risks and content gaps that could cause rejection or delay
- Reducing back-and-forth cycles with authorities
- Guaranteeing dossiers are aligned with the most recent requirements of drug authorities — so technical teams always focus on the right content, at the right time
👉 With Juphera, pharma companies no longer face uncertainty — instead, they achieve speed, compliance, and confidence in every submission.

What file formats does Juphera accept?

Currently, Juphera accepts PDF CTD Module 3 files only — in the same structured, readable format required for submission to drug authorities.

Is Juphera only for generic drugs?

At this stage, yes — Juphera is optimized for generic pharmaceutical submissions, where time, cost, and compliance challenges are most critical. Expansion to biologics/biosimilars is being considered.

What results can we expect with Juphera?

- ⏳ Our mission and target: reduce review cycles from 12 months → 10 days
- 📉 Up to 80% fewer submission errors
- 💰 Significant cost savings for both regulators and pharma companies
⚠️ Note: This 10-day review target is our vision and mission — it can only be achieved when both pharma companies and drug authorities adopt Juphera collaboratively.

Are pharma companies outside Saudi Arabia able to use Juphera?

Yes. Any pharma company worldwide can use Juphera if they are targeting submissions to the Saudi FDA, since this is the first authority Juphera is trained on.

In the future, Juphera will expand to other drug authorities. Once your targeted authority is supported, you will be able to use Juphera for those markets as well.

👉 If you want to be notified when Juphera becomes available for additional authorities, [fill out this form] to stay updated.

Saudi FDA Module

Complies with SFDA CTD format Detects non-conformity to Saudi-specific expectations Suggests corrections based on national guidelines

EDA Module

Built for Egyptian Drug Authority requirements Includes section-specific validation and national submission alignment

Future Roadmap

Jordan FDA module (in development) Predictive analytics for submission approval risk Integration with submission management systems (planned)

Pricing Overview

Simple, Scalable Pricing Juphera will offer flexible billing: Annual Subscription Usage-Based Tiers Final pricing to be announced at launch.

EDA Module

Built for Egyptian Drug Authority requirements Includes section-specific validation and national submission alignment

Call to Action

Explore How Juphera Can Work for You Book a personalized demo to see how Juphera improves regulatory review and submission quality.

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Platform Highlights

Upload

Submit your structured CTD Module 3 dossier in PDF format.

Analyze

Our AI identifies and interprets technical sections using NLP — including formulation, control, and analytical data.

Validate

Juphera flags inconsistencies, missing info, and compliance gaps — tailored to the selected regulatory body.

Report

Get a clear, organized validation report with risk flags and improvement suggestions.

Who Juphera is for?

For Regulatory Authorities:

Automate validation and structure checks.
Increase consistency and reduce human workload.
Align reviews with national compliance frameworks.

For Generic Pharma Companies: -
Catch gaps before submission.
Reduce rejection risk and rework.
Get Al-generated insights for faster approvals.

Contact us through below bottoms if you are: -

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