Passion to ensure quality medicine for the People
Driven to provide the most Accurate, Affordable, Specialized and Speedy regulatory service
Dedication to your Success, From Concept to Approval
We are a professional team of Medicine Regulatory Expert Consultants serving the Pharmaceutical, Device and Veterinary industries ensuring quality medicine and device applications.
Compilation and updating of Medical Device registration dossiers
- Performing due diligence on data to ensure compliance to latest regulatory guidelines.
- Compilation of medical device registration dossiers according to the latest SAHPRA guidelines and international standards.
- Assist with Manufacturer/Distributor/Wholesale license for devices
Compilation and updating of registration dossiers for Orthodox Medicines – Pharmaceutical, Biological and Complimentary medicine
- Performing due diligence on data to ensure compliance
- Compilation of ZA CTD/eCTD submissions including vaccines/biosimilars/new chemical entities/ generic medicine and complementary medicines (CAMS)
- Compilation of Baseline eCTD submissions and compilation of SCoRE document (Summary of Critical Regulatory Elements)
- Response to the Health Regulatory Authority recommendations
- Conversions of MBR1/MRF1 to the current ZA CTD and eCTD Format
- Compilation of eCTD dossiers according to SAHPRA standards with EQUALS ® document management software
- Updating to the Clinical, Pharmaceutical and Analytical sections of the MRF1/ZA CTD
- Transfer of Applicant
- Compilation of Package Inserts, Patient Information Leaflets and Summary of Product Characteristics (SPC).
- Post-registration updates to the Package Inserts and Patient Information Leaflet
- Compilation and updating of Registration dossiers of farm feeds and agricultural remedies (Act 36)
- Compilation and updating of registration dossiers of Veterinary products (Act 101)
- Compilation and submission of applications to other African countries (ZaZiBoNa, Kenya, Uganda, Mauritius etc) – Compilation of QOS, QIS, BTIF and complete dossier according to each country’s individual requirements
- Licensing – The compilation and submission of Applicant, Manufacturer, Wholesale and Distribution licenses to the Department of Health (DOH), South-African Pharmacy Council (SAPC) as well as the South African Health Products Regulatory Authority (SAHPRA).
- Facility Audits – Local and international as per SAHPRA and WHO requirements.
- Advertising compliance
- Copy, printing and binding
Our team provide the best quality, value-based, expert service offering in the regulatory, legislative and GMP/GLP compliance environments for the pharmaceutical and healthcare products in South Africa and Africa
With us you
- Have peace of mind, your products are in expert hands.
- Shorten your time to market with precise submission.
- Avoid unnecessary costs and delays.
- Access to broad international experience.
We view the relationship with clients as a partnership
Whether you are a start-up, middle state or large multinational Pharmaceutical company, you can count on Louise Els Consultants to help you grow your business.
Your products have the potential to improve life for millions around the world. To reach it fullest potential, each product must meet various complex and rigorous standards. Louise and her team is a dependable business ally with domestic and international regulatory expertise.
We empower you with the latest information and explain the regulatory environment to ensure compliance, related to your products. This enables you to make informed decisions resulting in higher profit margins.
- Bring their products to market faster.
- Extend the business globally with minimum risk and reduced cost.
- Focus on their core business while we are handling all their regulatory, clinical, quality and GMP requirements.
- Operate continuously in compliance with local and global regulatory requirements and quality standards.
Specialized team consisting of expert regulatory pharmacists and regulatory scientists with overall 32 years of cumulative regulatory expertise.
Providing experience, expertise, flexibility, professionalism, efficiency to meet your most challenging objectives.
Get in touch
Cell: +27(0) 82 417 7555
Tel: +27(0) 18 290 8595
Fax: +27(0) 86 557 8077