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Regulatory solutions & services for Life Sciences industry

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Freyr 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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Greetings from Freyr Nigeria

Freyr is one of the largest global, Regulatory-focused solutions and services companies. We support Life Sciences companies entering Nigerian Pharma market in their entire Regulatory value chain, ranging from Regulatory strategy, market intelligence, local representation, and post-approval product maintenance functions.

 

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key Regulatory Authority for regulating drugs in Nigeria. The NAFDAC regulates the registration of drugs, medical devices, food supplements, and cosmetic products. With our team of on-ground Nigerian Regulatory experts, we ensure a smooth and successful market entry of your products in Nigeria.

 

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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Freyr Digital

Freyr SUBMIT PRO
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
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Freyr IMPACT
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Freyr Label 360
Freyr Label 360 The Real-time is Now REAL Content To Carton.
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Freyr PRISM
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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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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