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Clear Paths , Fast Track

Compliance for MENA 

We simplify pathways for Pharmaceuticals, Cosmetics, and Medical Devices

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Welcome to Kernel Healthcare

We stand out through the region’s foremost regulatory consultants, who adeptly navigate MENA’s complex regulatory landscapes with unparalleled efficiency and expertise. When connected with us, you’re never navigating compliance on your own. We stand behind your success, leveraging our regulatory expertise to support the growth of your entire team and organization.

    

About Us

​Why Choose Us?

At Kernel Healthcare, we don’t just understand regulatory challenges—we solve them.

Get your product to market with confidence through expert Regulatory Affairs support. Whether it’s compiling technical files, managing dossiers, or coordinating with regulatory bodies, we handle the details so you can focus on innovation. Keep your business compliant and competitive with Kernel Healthcare by your side.

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    Our Mission​

To provide advanced, integrated regulatory affairs and market access services that empower healthcare innovators to bring safe, effective products to the MENA region—ultimately advancing patient outcomes, consumer safety, and public health.

​    Our Vision

To become the leading partner in product registration and regulatory affairs throughout the MENA region, championing scientific excellence and elevating global healthcare standards by facilitating safe, effective, and accessible medical innovations. 

Bringing a medical product to market is incredibly complex. But, at Kernel Healthcare, we have the skills and knowledge required to ensure complete regulatory compliance. We are here for you every step of the way.

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 At Kernel Healthcare ,

Our commitment extends beyond regulatory approvals. By partnering with us, you join a community dedicated to leveraging science, strategy, and compliant solutions for a healthier, safer world.

From Rules to Results 

We Make Compliance Your Competitive Edge

Regulatory Pathway Determination


We provide end-to-end support selecting the most effective and efficient regulatory pathway for your product. By analyzing regional regulations, risk levels, and data requirements, our team identifies the optimal route to expedite approvals. 

Regulatory Dossier Preparation and Submission

 We expertly compile essential product information, from clinical data to manufacturing protocols, presenting it in the required format and structure. We use our agency relationships to expedite reviews and ensure swift MENA approvals.


Labeling Review and Localization


Our team understands that an effective label does more than inform—it builds trust. We ensure that your product labeling resonates with regional consumer bases and complies with local linguistic and regulatory mandates. 

Consultation


 We deliver specialized regulatory affairs consultation meticulously crafted to navigate the dynamic complexities of healthcare product oversight. We devise bespoke strategies that optimize product registration, expedite approvals, and safeguard ongoing regulatory alignment. 

Active Regulation Tracking


Our specialized monitoring services keep you informed about new or updated regulations, policies, and guidelines across MENA jurisdictions. By providing regular intelligence reports and strategic advice, we enable agile adjustments to your product strategies, safeguarding compliance and fueling a competitive edge in rapidly shifting markets. 


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Post-Market Services


Once your product hits the market, ongoing safety and performance monitoring becomes critical. Our services involve collecting, analyzing, and reporting real-world evidence to detect adverse events swiftly. We help you uphold compliance  and sustain long-term consumer trust in the MENA region.


Our References

Strong Network with the Regulatory Bodies in the MENA region

Frequently Asked Questions (FAQs)

We primarily focus on pharmaceuticals, medical devices, and cosmetics products. However, we adapt our services to any product that falls under regulatory oversight in the MENA region.

We extend our services across the majority of MENA countries, including Saudi Arabia, the United Arab Emirates, Jordan, Egypt, Kuwait, Qatar, Bahrain, Oman, Lebanon, and more.

Timelines differ based on product type, regulatory complexity, and the specific authority involved. We work diligently to expedite submission processes, ensuring regulatory alignment from the outset to minimize delays.

Absolutely. Kernel offers professional translation and localization services to ensure that all packaging, labeling, and marketing materials meet the linguistic and regulatory demands of each MENA country.

Absolutely. We assist with post-marketing surveillance, renewal applications, labeling updates, and any additional compliance requirements.

Simply reach out via our Contact Us page. Our team will schedule a meeting to understand your product profile, objectives, and timelines, after which we will craft a tailored solution.