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.

Expertise

Choose your sector

Core services

Pharmaceuticals
Registration & Lifecycle Services

Regulatory pathway & strategy

Classification, eligibility, reference country strategy, fast-track options, bridging/risk-based approaches.
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Dossier authoring & publishing

CTD/eCTD preparation, Module 1 localization, GMP/CPP/FSC coordination, stability & bioequivalence evidence mapping.
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Labeling & artwork

Local language requirements, claims/legal text, serialization/readability alignment.
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Authority submissions & coordination

End-to-end filing, questions/RFI handling, meeting prep, deficiency responses.
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Post-approval changes & renewals

Variations, line extensions, renewals, pharmacovigilance setup in-market.
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Regulatory intelligence

Ongoing updates and impact assessments for MENA markets.
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Core services

Medical Devices
Market Authorization & Vigilance

Device classification & pathway.

Market-wise classification, GHTF/IMDRF alignment, documentation gap analysis.

Technical documentation

STED/CE-style files, GSPR mapping, risk management (ISO 14971), clinical/performance evidence, UDI/traceability planning.

Local language labeling & IFU localization

Country-specific requirements and artwork control.

Authority submissions & liaison

Dossier assembly, submissions, and deficiency management; coordination with local authorized reps where needed.

Post-market surveillance & vigilance

PMS plans, incident reporting, periodic safety updates, FSCA/recall support.

Core services

Cosmetics
Notification, Claims & Labeling Compliance

Product notification/registration

Market-specific pre-market notifications and listings; responsible person/local authorization where required.

Safety & claims substantiation

Ingredient review vs. local positive/negative lists, safety assessment coordination, efficacy/claims substantiation and evidence mapping.

Labeling & artwork localization

INCI nomenclature, mandatory statements, language requirements, shelf-life/PAO icons and claims alignment.

Dossier & documentation

PIF/CPNP-style files adapted to local frameworks; BoM, CoA, MSDS collation.

Regulatory surveillance

Ingredient list updates, restriction changes, and compliance alerts across the region.

Strong Network with the Regulatory Bodies in the MENA region

Our References