PRA Consultancy

PRA Consultancy Professionals Regulatory Affairs, (PRA) is a Middle East Healthcare regulatory affairs consultancy,

Professionals Regulatory Affairs (PRA) is a consultancy firm based in Dubai that advices and helps companies register pharmaceutical, medical devices, cosmetics, personal care, supplements, veterinary, herbal products & toys with authorities in the GCC region. The firm also offers other services like eCTD file preparation, translation of artwork from English to Arabic and vice versa complying with

the regional labelling guidelines. It has an impressive foothold in Middle East that benefits companies in finding their distributors through us. With its extensive expertise, strong network and reliable connections, the firm can also assist in doing the credibility check of distributors and market access of products in the region.

27/05/2026

We warmly extend our sincere greetings and best wishes to you and your loved ones on the occasion of Eid Al-Adha.

This blessed occasion reminds us of the enduring values of faith, generosity, and compassion. May these values continue to guide and inspire you in both your personal and professional journey.

Wishing you a peaceful, joyful, and prosperous Eid Al-Adha.

MENA UAE

27/05/2026

We warmly extend our sincere greetings and best wishes to you and your loved ones on the occasion of Eid Al-Adha.

This blessed occasion reminds us of the enduring values of faith, generosity, and compassion. May these values continue to guide and inspire you in both your personal and professional journey.

Wishing you a peaceful, joyful, and prosperous Eid Al-Adha.

25/05/2026

Did you know? “Aesthetic products are NOT standard cosmetics.”

In the GCC, they follow different regulatory pathways, and misclassification can lead to delays or rejection.

Here are the key differences:

• Purpose: esthetic products act on the body to modify or enhance appearance (e.g., injectables, fillers), while cosmetics are limited to cleansing, beautifying, or protecting without affecting physiological functions.

• Use: Aesthetic products often involve invasive or professional application (e.g., injections), with a direct physiological impact. Cosmetics are non-invasive, intended for external use, and have a superficial effect.

• Regulation: Aesthetic products are typically regulated as medical devices or pharmaceuticals, requiring stricter approvals and supporting data. Cosmetics follow a simpler notification/registration process due to their lower risk profile.

Getting this right is critical for market entry.
Contact us: www.pra-me.com

BLOG ALERT! “Herbal Products in the GCC: Natural Doesn’t Mean Unregulated”As the demand for herbal and natural products ...
22/05/2026

BLOG ALERT!

“Herbal Products in the GCC: Natural Doesn’t Mean Unregulated”

As the demand for herbal and natural products continues to grow across the GCC, regulatory authorities are increasing their focus on product safety, quality, compliance, and market authorization.

Many companies assume that “natural” products face fewer regulatory requirements; but in reality, herbal products must still comply with strict regulations before entering GCC markets.

Read the full blog here: https://pra-me.com/herbal-products-in-the-gcc-natural-doesnt-mean-unregulated/

At PRA Consultancy , diversity is not just something we celebrate once a year; it’s part of who we are every single day....
21/05/2026

At PRA Consultancy , diversity is not just something we celebrate once a year; it’s part of who we are every single day.

Our team brings together professionals from different cultures, backgrounds, and perspectives.

This diversity strengthens how we think, collaborate, and deliver value to our clients in the healthcare and regulatory space.

Today, on the occasion of World Day for Cultural Diversity, we take a moment to appreciate the unique experiences each team member brings, and how these differences drive innovation, understanding, and unity.

To our team: thank you for making PRA Consultancy a global and inclusive workplace.

Let’s continue to learn from one another, respect every voice, and grow stronger together.

UAE Regulatory Update: "Second Distributor is Now a Must"The Emirates Drug Establishment (EDE) is moving away from the s...
20/05/2026

UAE Regulatory Update: "Second Distributor is Now a Must"

The Emirates Drug Establishment (EDE) is moving away from the single distributor model.

Companies are now expected to appoint more than one agent/distributor to ensure product availability and avoid supply disruptions.

This changes everything; relying on one local partner is no longer enough.
You need a structured multi-distributor strategy, compliant, efficient, and well-managed.

How PRA can support you:
- Identify and onboard the right second distributor
- Structure a compliant multi-agent setup
- Handle regulatory alignment with EDE
- Ensure smooth coordination across partners

This is not just compliance; it’s an opportunity to expand smarter in the UAE.

Let PRA help you adapt fast and stay ahead: www.pra-me.com

Is your pharmaceutical operation fully GMP compliant?Good Manufacturing Practice (GMP) is not just a requirement; it’s t...
19/05/2026

Is your pharmaceutical operation fully GMP compliant?

Good Manufacturing Practice (GMP) is not just a requirement; it’s the foundation of quality, safety, and regulatory approval across the product lifecycle.

In the GCC, authorities increasingly align with EU GMP standards, making compliance essential for market access and inspections.

At PRA Consultancy, we support you with:

• GMP implementation & quality management systems (GxP)
• Audit readiness & regulatory compliance support
• Process optimization & structure development
• Qualified Person (QP) services (short & long term)

From system setup to certification, we ensure you’re inspection-ready.
Get expert support: www.pra-me.com

Nutraceuticals (herbal) are booming across the GCC, with the market expected to exceed $3–5 billion by 2027.But here’s w...
18/05/2026

Nutraceuticals (herbal) are booming across the GCC, with the market expected to exceed $3–5 billion by 2027.

But here’s what most companies underestimate:
The same product can be classified differently across the region.

In one country: a food supplement; in another: a regulated medicinal product.

That one difference can completely change:
• Approval timelines
• Documentation requirements
• Claims you’re allowed to make

Most delays in nutraceutical registration don’t come from the product.
They come from getting the regulatory pathway wrong from the start.

In the GCC, success is not about submitting faster.
It’s about classifying smarter.

SaMD (Software as a Medical Device) is not “just software.” In the UAE, it follows a defined regulatory pathway.SaMD is ...
14/05/2026

SaMD (Software as a Medical Device) is not “just software.” In the UAE, it follows a defined regulatory pathway.

SaMD is classified as a standalone category, with its own considerations for risk, validation, and compliance. It is regulated under Emirates Drug Establishment (EDE), with their own considerations for risk, validation, and compliance.

One of the biggest challenges, is that companies often underestimate regulatory expectations because there is no physical product.

At PRA Consultancy, we assist SaMD companies in navigating UAE registration processes, managing regulatory submissions, and ensuring compliance with local requirements.

Planning to enter the UAE with a digital health solution?
Let’s talk: www.pra-me.com

Quality issues in pharma are rarely random; they’re systemic.Recent inspection data shows:• FDA inspections increased by...
12/05/2026

Quality issues in pharma are rarely random; they’re systemic.

Recent inspection data shows:
• FDA inspections increased by 27% in 2024
• Over 100 warning letters issued; highest in 5 years
• 25–35% of repeat findings are linked to process deviations

And the pattern is consistent:

The problem is not isolated errors; It’s weak quality systems.

Quality is not what you document.
It’s what your system consistently delivers.

Address

Port Saeed, Business Village, Block B, Office No. 615
Dubai
181559

Opening Hours

Monday 08:00 - 17:00
Tuesday 08:00 - 17:00
Wednesday 08:00 - 17:00
Thursday 08:00 - 17:00
Friday 08:00 - 17:00

Telephone

97142999398

Website

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