Registrations and Approvals

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

Pharmaceuticals Regulatory Services
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
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 Device
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 Almasa Aldwaeia, we help manufacturers overcome the barriers in preparing strong regulatory strategies, 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.

ou can benefit from our broad technical registration expertise and in-depth knowledge of local regulations.

We are your single point of contact for all regulatory matters, as well as commercial and distribution services.

 

Regulatory consulting

Preparing smooth market entry with:​

  • Regulatory feasibility assessment
  • Labeling requirement assessment
  • Product classification assessment
End-to-end product registration

Handling the entire product registration with:

  • Dossier preparation
  • Compliance checks
  • Product sample submission
  • Dossier submission
  • Registration follow-up and monitoring
  • Regulatory approval
Ensuring products follow the regulations

throughout their life cycle with:

  • 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.

Almasa Aldwaeia representative can assist you by providing the exact information you need to make an informed decision. Please Contact us.