Nutraceuticals
Pharmaceuticals
& Medical Devices
Pharmaceuticals, Nutraceuticals & Medical Devices
Regulatory Services
Registrations and Approvals
your reliable regulatory partner, ensuring products follow the regulations throughout their life cycle.
Pharmaceuticals Regulatory Services
We provide end-to-end regulatory services: from initial assessment, dossier preparation and submission to approval as well as the entire range of post-marketing services that are required.
Nutraceuticals Regulatory Services
With ever continues changes and updates to regulatory matters related to Libya's FDCC compliance and import of Nutraceuticals and Food Supplements, all related assistance is handled by us with strategic planning and technical acumen.
Medical Devices Regulatory Services
With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect
At Akeel, we assist manufacturers in navigating the complexities of regulatory strategies, including those specific to the Libyan Ministry of Health (LMOH). Our comprehensive services cover every stage, from initial assessments and dossier preparation to submission, approval, and all necessary post-marketing services, ensuring compliance with LMOH regulations.
With our extensive technical registration expertise and deep understanding of local regulations, including those set by the Libyan Ministry of Health, we ensure your compliance at every step.
We serve as your dedicated point of contact for all regulatory, commercial, and distribution needs, offering specialized support tailored to the Libyan market.
Pre-Registration
Regulatory consulting
Preparing smooth market entry with:
Registration
End-to-end product registration
Handling the entire product registration with:
Marketing
Ensuring products follow the regulations throughout their life cycle with:
Our services includes;
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Regulatory feasibility assessment
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Labeling requirement assessment
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Product classification assessment
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Dossier preparation
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Compliance checks
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Product sample submission
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Dossier submission
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Registration follow-up and monitoring
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Regulatory approval
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Marketing Authorization (MA) holding, maintenance and transfer
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Variations (minor and major)
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Renewal
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Advertising compliance check
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Pharmacovigilance
LIBYAN MARKET ENTRY
( LMOH Drug Registration Requirements )
Reliable regulatory partner, ensuring products follow the regulations throughout their life cycle.
Akeel representative can assist you by providing the exact information you need to make an informed decision. Please Contact Us today