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.

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

Regulatory Strategy & Classification

Product Categorization: Determine if it’s a drug, device, or cosmetic
Approval Pathways: Choose standard, expedited, or conditional routes

Dossier Compilation & Submission

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

Regulatory Authority Engagement

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

Labeling & Packaging Compliance

Local Label Requirements: Adapt global packaging to national regulations
Patient/Consumer Leaflets (PILs): Ensure clarity, accuracy, and language compliance

Medical Device-Specific Services

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

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.