Freyr is supporting global Top 5 and Fortune Pharma/Biotechnology/Consumer and Medical devices companies with end-to-end strategic Regulatory services for their strategic Regulatory needs across new emerging markets like Africa including the South Africa, Sub Sahara and North Africa regions.
End-to-End Regulatory Services - Africa Markets
- Dossier Preparations, Review, Compilation and Submission of new Marketing Authorization Applications including supporting data
- CTD Conversion:
- Gap Analysis between the old format and new ZA CTD (Common Technical Document for South Africa) format which is mandatory as per the South African Health Products Regulatory Authority (SAHPRA) [formerly known as MCC]
- Dossier harmonization and Master Dossier Preparation based on CTD format and enabling companies to address the need for reusability of the dossiers for other markets in Africa outside South Africa (saving time for multiple country specific applications)
- Life Cycle Management (Variations/Amendments Preparations and Submissions)
- Compilation and Review of Package Inserts, Patient information leaflets and Labels
- Regulatory Submission & Publishing Services including eCTD Compilation
- Regulatory Labeling & Artwork Services
- Regulatory Market Intelligence and submission strategy for Sub-Sahara and North Africa regions
- GMP Support:
- Audits and inspections (internal and external)
- Quality manuals
- Standard Operating Procedures
- Product Quality review services
Africa Countries and Sub Sahara Regions Covered
- South Africa
- Ghana
- Kenya
- Nigeria
- Angola
- Uganda
- Namibia
- Zimbabwe
- Zambia
- Mauritius
- Tanzania
- Botswana
- Malawi
Drugs Registration Services
Freyr Regulatory Affairs Consulting team consults and supports the sponsor applicants in the following areas of:
- Submission of all market authorization applications and supporting data to the SAHPRA in English (British)
Applications can include New chemical entity applications- Multi source/generic applications and innovator product line extension applications
- Innovator line extension applications and Biological medicines
- Submission of Site Master File (SMF) in accordance with the SMF guideline
- Support the applicant in expedited review request to the Ministry of Health for the attention of the Registrar of Medicines
- Dossier compilation for medicines registration including updates, lifecycle management
- Compilation and review of package inserts, patient information leaflets and labels
Freyr Good Manufacturing Practice Services
Freyr provides guidance to Sponsors in cGMP matters and related:
- Audits and inspections (internal and external)
- Site master files
- Quality manuals
- Standard operating procedures
Freyr CTD Conversion Services
Freyr provides the following services in supporting customers to meet the CTD mandate.
- Gap analysis between the old format and new CTD format
- Dossier harmonization and master dossier preparation based on CTD in enabling companies to address the need for reusability of the dossiers for other markets in and outside South Africa
- Provide a cost effective phased approach in meeting CTD mandate based on the number of product registrations and product registration priorities
Freyr Regulatory Operations Services
Freyr supports Market Authorization holders to manage their product registration data, Health Authority (HA) commitments data, post approval safety and manufacturing change communication data including the current Regulatory status of their products outside South Africa to meet the compliance and reporting needs of the SAHPRA.