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Pharmaceutical Expertise

  • End-to-end Pharmaceutical Product Registration 
  • Authorized Local Agent Support 
  • Manufacturing Site Approval Support
  • Import License Support
  • Pharmaceutical Dossier Preparation and Submission to the NAFDAC
  • Trademark Registration
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Overview of the Nigerian
Regulatory Landscape

National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority for regulating drugs in Nigeria. The Agency was established by Decree No. 15 of 1993 as amended by Decree No. 19 of 1999. Now, the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 is responsible for regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of Drugs.

 

Industries We Serve

National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority for regulating drugs in Nigeria. The Agency was established by Decree No. 15 of 1993 as amended by Decree No. 19 of 1999. Now, the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 is responsible for regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale and use of Drugs. 

Freyr Expertise

  • End-to-end Pharmaceutical Product Registration 
  • Authorized Local Agent Support 
  • Manufacturing Site Approval Support & Trademark registration
  • Pharmaceutical Dossier Preparation and Submission to the NAFDAC
  • Query Support Management till Approval
  • Product maintenance & compliance
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National Agency for Food and Drug Administration and Control (NAFDAC) is the key drug Regulatory Authority for regulating drugs and medical devices in Nigeria. The Agency was established by Decree No. 15 of 1993, as amended by Decree No. 19 of 1999. All Medical Devices should be registered in accordance with the provisions of NAFDAC act CAP N1 (LFN) 2004, other related legislations and the accompanying guidelines.

Freyr Expertise

  • End-to-end Medical Device Registration
  • Local Authorized Representation
  • Regulatory Consultation & Support on Medical Device Regulations
  • Sample Import Permit and Testing Co-ordination Services
  • Trademark Registration
  • Advertising Permit Management
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National Agency for Food and Drug Administration and Control (NAFDAC) is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution of the food products in Nigeria. It is necessary to emphasize that, no food products shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of Act CAP N1 (LFN) 2004, other related legislations and the accompanying Guidelines.

Freyr Expertise

  • Regulatory Strategy for Nigeria
  • Product Classification
  • Formula Review/Ingredients Assessment
  • Label and Claims Review
  • Compilation and Submission of Dossier to Health Authority
  • Legal Representation
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In Nigeria, cosmetic products are regulated under the National Agency for Food and Drug Administration and Control (NAFDAC) Act CAP N1 (LFN) 2004. The beauty and personal care sector in Nigeria are blooming and the increasing competition is said to drive the demand for innovative products in the region. In addition, intensive marketing activities are also boosting the growth of the sector. Thus, making Nigeria one of the most promising emerging markets for cosmetics companies to invest, while exploring the local manufacturing opportunities as well.

Freyr Expertise

  • Regulatory Support Services & Cosmetics Registration in Nigeria
  • Trademark Registration
  • Local Representation
  • Notarizing of Necessary Documents
  • Post-approval Support like Re-registration, Cosmetics Notification for Registration for Listing, Endorsement
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Support, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

 
 
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