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Our Services

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Registration Applications

Human Medicine

Product Registration
Import, Export, Distribution, Wholesale & Manufacturing Licensing

Veterinary Medicine

Product Registration

Veterinary Medical Devices

Product Registration

Agricultural Products

DAFF Applications
(Farm Feeds, Pesticides & Agricultural Stock Remedies)

Dental

Product Registrations

Complementary Medicines

Product Registration
Import, Export, Distribution & Wholesale Licensing

Medical Devices

Product Registration
Import, Export & Distribution Licensing

Foodstuffs and Cosmetics

Product Registration

Pipetting Samples
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Import/Export License Applications

We have partnered with a specialist in the Import and Export industry that will assist with all the necessary documentation for International and local trade 
(SARS Import/Export license, International Bank accounts and Custom clearance)

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Other Services

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  • Pharmaceutical legal advice 

  • (Creation, Sale, Patents, Distribution and use of Pharmaceutical Products within the South Africa climate)

  • Compilation and updating of registration dossiers 

  • eCTD/CTD/MRF (All Parts/Modules of industry related products) for New Chemical Entities (NCE), Generic medicines, Vaccines and Complimentary medicines (CAM)

  • Registration of Veterinary products, farm feeds, pesticides and agricultural remedies under Act 36 and Act 101  (DUFF/SAHPRA/SADC)

  • Compilation and updating of Medical Device registration dossiers for purposes of medical device registrations.

  • Complementary medicine applications

  • Amendments/ Variations for  submission to the regulatory authorities

  • Compilation of license applications for SAHPRA and SADC member states

  • Site Master Files (SMF)

  • Standard Operating Procedures (SOP) for regulatory departments as requested for applications.

  • Quality Manual (QM)

  • Professional Information and Patient Information Leaflet and Label as well as Translations thereof.

  • Screening and assessing of data to ensure compliance with registration requirements and feasibility to proceed with an application for successful registration.

  • Liaison and electronic communication with the Regulatory Authorities

  • Facility Audits –Local and international as per legislative and industry (local and international)requirements

  • Compilation and support for self-audits

  • Licensing – Compilation and submission of Applicant, Manufacturer, Wholesale and Distribution licenses to the Department of Health (DOH), South-African Pharmacy Council (SAPC) as well as SAHPRA.

  • Conversions of MBR1/MRF1 to CTD and eCTD required formats

  • Response to the Health Regulatory Authority recommendations

  • eCTD submissions to SAHPRA (Electronic submission)

  • Import/Export/Distribution/Manufacturing and Wholesale License for Medical devices

  • Import/Export/Distribution/Manufacturing and Wholesale License for Human medicines

  • Import/Export/Distribution/Manufacturing and Wholesale License for Complementary medicine

  • SARS registration of Import / Export license

  • Section 21 applications

  • Compilation of Quality Overall Summary (QOS), Summary of critical Regulatory Elements (SCoRE),Quality Information Summary (QIS), Bioequivalence Trial Information Form (BTIF) and a Biowaiver Application according to all SADC countries requirements.

  • Renewal applications for applicant licenses and products (SADC and EAC)

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