REGULATORY AFFAIRS

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Transforming regulatory complexity into strategic simplicity 

Product Types

Registration of different product types can have a vastly different process in the various African countries. Vicore can assist in finding the correct approach for each of the unique environments.

 

Vicore specialises in the registration, advisory, licensing or listing of the following product types:

  • Pharmaceutical Medicines

  • Complementary Medicines

  • Medical Devices and IVDs

  • Cosmetics

  • Borderline products

Services

Licensing and Compliance

  • Licence applications and renewals

  • QMS establishment and guidance (Standard Operating Procedures, Site Master Files, Quality Manuals, etc.)

  • GxP guidance

  • Audit preparation guidance

  • Acquisition advisory and regulatory due diligence on companies

  • Advisory on conformity requirements applicable to specific licences and/or products (e.g., ISO certification)

Regulatory Services

  • Regulatory Advisory on regulations, requirements, harmonization initiatives, product prioritisation, advertising and medical claims

  • Product Classification (determined according to each country’s specific requirements)

  • Conducting Due Diligence on registration dossiers for New Chemical Entities (NCEs), Generic/Multisource Medicines, Biologicals and Biosimilars

  • Dossier Compilation for registration submissions

  • Life-cycle management (variations and updates) of registered and dormant products

  • Compilation and review of Professional Information (Summary of Product Characteristics (SmPC)), Patient Information Leaflets, Labels and Artwork

  • Documentation publishing in eCTD format using DocuBridge

  • Clinical Trial advisory and application
     

Regulatory Intelligence

  • Detailed intelligence on regulations, requirements and processes for specific African countries.

  • Our intelligence spans over multiple facets of the pharmaceutical industry, such as product-specific intelligence, pre-registration (Clinical trials), registration & post-registration (variations and renewals)

  • We have strategic connections with in-country contacts and national health authorities to ensure up-to-date intelligence within each market, in order to provide the most accurate representation of the processes required for market expansion.

Translation Services

  • Translation of Professional Information (Summary of Product Characteristics (SmPC)), Patient Information Leaflets, labels and artwork, promotional and marketing material

  • Our team can offer translation services in English, Afrikaans, French and Dutch

Digital Offerings

  • Watch this space!

Other Services

  • Please contact us for any other specific services you may require.