PRA Consultancy

04/09/2026

How does Health Technology Assessment (HTA) shape healthcare decisions in Jordan?

As healthcare systems increasingly focus on value, outcomes, and sustainable spending, HTA is becoming an important part of informed decision-making.

In the latest episode of RAYA (Regulatory Affairs Your Advisor), explore an overview of Jordan’s HTA landscape, and its role in evaluating health technologies and supporting evidence-based healthcare and market access decisions.

Watch the full video on our YouTube channel: https://youtu.be/HK0GdAl6KVo?si=AeD0C0OoKQRRDS4-

Planning to import Active Pharmaceutical Ingredients (APIs) into th...

03/09/2026

Regulatory intelligence is not about collecting updates. It’s about knowing what to do with them.

Dr. Najiba Al Shezawy, our Co-Founder & Managing Director at PRA Consultancy , puts it in the following sense, where a new guideline may seem like a compliance update today, but its real impact can reach much further; influencing future submissions, market-entry timelines, portfolio priorities, and strategic decisions.

That’s where experience makes the difference: connecting today’s regulatory changes with tomorrow’s business realities.

The question isn’t only “What changed?”
It’s “What does this change mean for what we do next?”

www.pra-me.com

01/09/2026

Elevate your expertise in Pharmacovigilance with our comprehensive Pharmacovigilance GCC Training .

Designed for Pharmacovigilance Officers, Pharmacists, Regulatory Affairs professionals, and fresh graduates, this training provides practical knowledge and essential skills to strengthen your expertise and navigate the evolving pharmacovigilance landscape across the GCC region.

Whether you’re beginning your career in PV or looking to advance your professional profile, this program will equip you with the knowledge, practical insights, and confidence to take the next step in your pharmacovigilance career.

- Dates: November 7, 2026 – November 29, 2026

- Attendance: Onsite at Dubai Medical University – College of Pharmacy Online for participants outside the UAE

Register now and gain an exclusive 15% discount:
https://pra-me.com/pharmacovigilance-certification-course/

For more information: [email protected] | +971 56 298 8438

31/08/2026

Submitting an eCTD dossier? A final validation check can save weeks of unnecessary delays.

Some of the most common eCTD validation errors include:

- Missing or broken hyperlinks and bookmarks
- Incorrect file naming or folder structure
- Invalid XML backbone or sequence issues
- Missing mandatory documents
- PDF formatting or readability problems

Identifying and correcting these issues before submission helps reduce technical rejections and supports a smoother regulatory review process.In addition, it is always helpful to re-validate your application through second party softwares for a higher assurance rate of success.

Contact us for more practical regulatory insights: www.pra-me.com

26/08/2026

Planning to bring your healthcare products into the GCC or MENA?

For many international manufacturers, appointing a Local Authorized Representative (LAR) is a regulatory requirement before products can be registered and placed on the market.

A Local Authorized Representative helps:

- Ensure compliance with local regulations
- Ensure post-approval makret compliance according to GCC or MENA requirements
- Act as the official point of contact with health authorities
- Support product registration and post-market obligations
- Streamline market entry and reduce regulatory delays

According to the World Health Organization (WHO), strong regulatory systems are essential to ensuring the quality, safety, and effectiveness of medical products. A qualified Local Authorized Representative plays a vital role in helping manufacturers meet these regulatory expectations.

Partnering with the right LAR can simplify your market entry and keep your regulatory journey on track: www.pra-me.com

26/08/2026

In case you missed It, our webinar, “Introduction to NashraTech: A Practical Guide for Regulatory Professionals,” is now available to watch on YouTube!

Catch up on practical insights into NashraTech, Electronic Patient Information Leaflets (ePIL), QR code requirements, and evolving regulatory expectations across the GCC.

Watch the full webinar here: https://youtu.be/Y0n8_KrtiU0

The pharmaceutical industry across the GCC is moving toward digital...

25/08/2026

بمناسبة المولد النبوي الشريف، نتقدم بأطيب التهاني والأمنيات لكم ولأحبائكم.
نسأل الله أن تحمل هذه المناسبة المباركة السلام والخير والبركة للجميع.

On the occasion of Mawlid Al-Nabawi, PRA Consultancy extends its warmest wishes to you and your loved ones. May this blessed occasion bring peace, goodness, and prosperity to all.

24/08/2026

Regulatory Strategy vs. Regulatory Submission – Why They're Different
According to the U.S. Food and Drug Administration (U.S. Food and Drug Administration ), only 47% of New Drug Applications (NDAs) in one evaluation received approval in the first review cycle, while many others required additional review cycles due to deficiencies related to application quality, development planning, or communication with regulators. This demonstrates why regulatory success begins long before the submission itself.
A regulatory strategy is the roadmap. It defines the optimal registration pathway, identifies country-specific requirements, anticipates regulatory risks, and aligns market entry with business objectives.
A regulatory submission is the ex*****on. It is the preparation and submission of the required documentation to health authorities based on that strategy.
Why does the difference matter?
- A strong regulatory strategy reduces the risk of deficiencies and unnecessary review questions.
- It helps avoid costly delays and rework.
- It supports faster approvals and more efficient market access.
- It ensures your submission is built on the right regulatory pathway from the very beginning.
A successful submission doesn't start with compiling documents; it starts with making the right strategic decisions.

21/08/2026

BLOG ALERT!

In pharmacovigilance, important safety information does not come only from global databases and international publications. Local scientific and medical literature can reveal critical safety signals, adverse drug reactions, and region-specific evidence that may otherwise be overlooked.

Our latest blog, “The Growing Importance of Local Literature Monitoring in Pharmacovigilance,” explores why effective local literature monitoring is becoming an increasingly important component of a robust pharmacovigilance system.

Read the full blog on the PRA Consultancy website and explore the growing role of local literature monitoring in strengthening pharmacovigilance practices: https://pra-me.com/the-growing-importance-of-local-literature-monitoring-in-pharmacovigilance/

20/08/2026

We’ve just concluded our webinar, “Introduction to NashraTech: A Practical Guide for Regulatory Professionals,” and we would like to extend our sincere appreciation to everyone who made this session a success.

A special thank you to our distinguished speaker, Dr. Sultan Al-Ghamdi, Director, Public Affairs & Scientific Office at STADA Emerging Markets and our moderator, Dr. Azba Shaikh, Regulatory Affairs Expert – Middle East & Africa, for expertly guiding the discussion and contributing to an engaging and insightful session.

And, of course, thank you to all our attendees for joining us, participating, and making the webinar truly worthwhile.

Thank you for being part of this insightful webinar.
We look forward to welcoming you to our upcoming webinars!