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Regulatory Affairs & Product Registration  

Guiding Your Pharmaceutical, Medical Device & Cosmetic Innovations to MENA Market

Regulatory Solutions

Navigating the regulatory landscape for drugs, medical devices, and cosmetics can be complex, especially when local regulations vary widely. At Kernel, we offer comprehensive regulatory consultation in partnership with our sister company, ​Kernel Healthcare Regulatory Solutions, to help you streamline product registration, maintain compliance, and accelerate market access in Jordan, the MENA region, and beyond.


Explore the various regulatory services we offer

Pharmaceuticals

Bringing a medical product to market is challenging. We use our specialized expertise to ensure full compliance

Medical Devices

We will help your business Enter the MENA Market of medical devices and equipment.

Cosmetics

Explore our Cosmetics Regulatory Services. We assist brand owners, manufacturers, and distributors.

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. 

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

 See Region  

Why Choose Kernel’s Regulatory Affairs & Registration Services?

Concise, Action-Oriented Outputs

  •  Proficiency in MENA region guidelines (e.g., JFDA, SFDA, EDA)
  •  Familiarity with international standards (e.g., FDA, EMA, WHO)
  •  Expertise in clinical evidence bridging, ensuring your product data meets local regulatory expectations

Holistic Consultation & Strategy

  • End-to-end support, from regulatory classification (drug, medical device, or cosmetic) and dossier preparation to final submission
  •  Strategic planning for pre-market approvals, fast-track pathways, and post-market surveillance
  • Customized approaches for innovator drugs, generics, biosimilars, various device classes, and cosmetic products
Synergy with Kernel Healthcare Regulatory solutions
  • Seamless collaboration leverages Kernel Healthcare Regulatory solutions’ dedicated registration experts who focus on product submissions, follow-ups, and timely approvals
  •  Access to specialized local networks, expediting documentation exchange and bridging communications with health authorities

Core Services for Drugs, Medical Devices & Cosmetics  

  •  Product Categorization: Determine if it’s a drug, device, or cosmetic
  • Approval Pathways: Choose standard, expedited, or conditional routes
  • Document Prep: Assemble CTD, Technical Files, or Safety Reports
  • Translations & Formatting: Meet local language and style requirements
  • eCTD & Digital Platforms: Accelerate reviews with streamlined electronic submissions
  •  Pre-Submission Guidance: Address potential gaps and clarify requirements early
  •  Query Management: Provide data-driven justifications and responses
  •  Inspections & Audits: Support GMP, GDP, or site assessments for a smooth process
  • Local Label Requirements: Adapt global packaging to national regulations
  • Patient/Consumer Leaflets (PILs): Ensure clarity, accuracy, and language compliance
  • Classification & Conformity: Determine device class and compile essential documentation
  • Risk Management & Clinical Evaluation: Align with ISO 14971, demonstrate safety and performance
  • UDI & Traceability: Implement unique device identification for robust monitoring and recalls

Collaboration with Kernel Healthcare

Kernel Healthcare Regulatory solutions specialize in:



Local & Regional Submissions 

Expertise in Jordan (JFDA), Saudi Arabia (SFDA), Egypt (EDA), and Gulf Cooperation Council (GCC) pathways


Follow-Up & Negotiation

 Liaising with regulators to keep your application on track, clarifying any requests, and ensuring swift resolutions


Document Legalization & Attestation

 Handling embassy certifications, notary services, and local ministry attestations

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By working hand-in-hand, Kernel Research and Kernel Healthcare Regulatory solutions streamline both the technical and logistical aspects of registration, making your path to market faster and more efficient.

Let us simplify your approval journey, so you can deliver life-changing treatments to patients faster and more confidently than ever.

Contact us