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QPPV, PSMF, Pharmacovigilance (PV), and Regulatory Services Libya Akeel Health provides expert Pharmacovigilance (PV), QPPV, and PSMF services in Libya, ensuring regulatory compliance, patient safety, and effective risk management for the pharmaceutical industry. "Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network" Akeel Health is Libya’s leading pharmaceutical registration provider, specializing in securing product approvals from the Ministry of Health (MOH) and the National Medicines and Poisons Board (NMPB). The registration process requires submission of a comprehensive dossier in line with ICH and WHO guidelines, covering quality (CMC), preclinical, and clinical data. In addition, applicants must comply with local business licensing requirements, demonstrate GMP compliance, and meet national track-and-trace regulations, including GS1 DataMatrix implementation. Successful market entry often depends on working with an experienced local partner to efficiently navigate regulatory and administrative procedures.

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

 
QPPV, PSMF, Pharmacovigilance (PV), and Regulatory Services Libya Akeel Health provides expert Pharmacovigilance (PV), QPPV, and PSMF services in Libya, ensuring regulatory compliance, patient safety, and effective risk management for the pharmaceutical industry. "Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network" Akeel Health is Libya’s leading pharmaceutical registration provider, specializing in securing product approvals from the Ministry of Health (MOH) and the National Medicines and Poisons Board (NMPB). The registration process requires submission of a comprehensive dossier in line with ICH and WHO guidelines, covering quality (CMC), preclinical, and clinical data. In addition, applicants must comply with local business licensing requirements, demonstrate GMP compliance, and meet national track-and-trace regulations, including GS1 DataMatrix implementation.
"Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network"
Libya Medical Devices regulatory registerations Ministry of Health, "Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network"
QPPV, PSMF, Pharmacovigilance (PV), and Regulatory Services Libya Akeel Health provides expert Pharmacovigilance (PV), Libya QPPV, and PSMF services in Libya, ensuring regulatory compliance, patient safety, and effective risk management for the pharmaceutical industry."Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network" Akeel Health is Libya’s leading pharmaceutical registration provider, specializing in securing product approvals from the Ministry of Health (MOH) and the National Medicines and Poisons Board (NMPB). The registration process requires submission of a comprehensive dossier in line with ICH and WHO guidelines, covering quality (CMC), preclinical, and clinical data. In addition, applicants must comply with local business licensing requirements, demonstrate GMP compliance, and meet national track-and-trace regulations, including GS1 DataMatrix implementation

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.

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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.

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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; 
  • Regulatory feasibility assessment

  • Labeling requirement assessment

  • Product classification assessment

  • Dossier preparation

  • Compliance checks

  • Product sample submission

  • Dossier submission

  • Registration follow-up and monitoring

  • Regulatory approval

  • Marketing Authorization (MA) holding, maintenance and transfer

  • Variations (minor and major)

  • Renewal

  • Advertising compliance check

  • Pharmacovigilance

LIBYAN MARKET ENTRY
( LMOH Drug Registration Requirements )
 

Reliable regulatory partner, ensuring products follow the regulations throughout their life cycle.

QPPV, PSMF, Pharmacovigilance (PV), and Regulatory Services Libya Akeel Health provides expert Pharmacovigilance (PV), QPPV, and PSMF services in Libya, ensuring regulatory compliance, patient safety, and effective risk management for the pharmaceutical industry. "Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network"

QPPV, PSMF, Pharmacovigilance (PV) Regulatory Services Libya

 

Akeel Health provides expert Pharmacovigilance (PV), QPPV, and PSMF services in Libya, ensuring regulatory compliance, patient safety, and effective risk management for the pharmaceutical industry.

"Pharmaceutical Market Libya" "Libyan Pharmaceutical Registration" "Pharmaceutical Regulatory Services Libya" "Libya Drug Market Entry" "Libya Pharma Distribution Network" Akeel Health is Libya’s leading pharmaceutical registration provider, specializing in securing product approvals from the Ministry of Health (MOH) and the National Medicines and Poisons Board (NMPB). The registration process requires submission of a comprehensive dossier in line with ICH and WHO guidelines, covering quality (CMC), preclinical, and clinical data. In addition, applicants must comply with local business licensing requirements, demonstrate GMP compliance, and meet national track-and-trace regulations, including GS1 DataMatrix implementation. Successful market entry often depends on working with an experienced local partner to efficiently navigate regulatory and administrative procedures.

Akeel representative can assist you by providing the exact information you need to make an informed decision. Please Contact Us today

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