Exemplary Regulatory Solutions for the Pharmaceutical Industry

At DI Regulatory Consultants, we deliver cost-effective, professional regulatory consulting services to pharmaceutical and healthcare companies across South Africa, SADC countries and other English-speaking Sub-Saharan African nations. Our experienced team stays ahead of evolving SAHPRA requirements, offering dependable guidance with attention to detail and industry insight.

Here’s how we help your business stay compliant, efficient and ready for market:

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Regulatory Consulting Services

We support clients through the entire product life-cycle, from new registrations to variations and updates. Our services include:

  • New medicine registration applications
  • Compilation of professional information (PI) and patient information leaflets (PIL)
  • Responses to SAHPRA queries
  • Quality, clinical and administrative variation submissions
  • Life-cycle management

We work across human, veterinary and complementary medicines—offering a deep understanding of medicine registration requirements in South Africa and beyond.

Licensing & Quality Management Systems (QMS)

Whether you need to set up a QMS or require support with inspections and audits, our team ensures your compliance framework is built on global best practices.

Services include:

  • Licensing for pharmaceutical applicants (SAPC, DOH, SAHPRA)
  • SOP development
  • Quality Manuals (QM) and Site Master Files (SMF)
  • Full QMS implementation aligned with ISO 13485 for medical devices
  • Internal and external GxP audits

We provide quality assurance and QMS consulting in South Africa, tailored to your business needs.

Medical Devices & ISO 13485 Compliance

Navigating regulatory frameworks for medical devices? We offer end-to-end support for:

  • Medical device licensing
  • ISO 13485 system implementation
  • Technical documentation and compliance strategies

We help ensure that your medical devices meet both local and international standards.

Complementary Medicines & Health Products

We provide compliance solutions for:

  • Licence applications for complementary medicines and health supplements
  • Product compliance and submission
  • Labelling and leaflet compliance
  • Evaluating and updating SAHPRA product lists

We’re trusted by brands needing complementary medicines consulting that is both meticulous and up to date.

Veterinary Medicines, Cosmetics & More

We manage product registration and life-cycle support for:

  • Veterinary medicines (under Act 101 and Act 36)
  • Cosmetic product compliance
  • Applications for both local and regional markets
  • Agricultural products (Act 36)

Regional Regulatory Support - SADC & Beyond

With extensive knowledge of regulatory requirements in South Africa, SADC countries and across English-speaking Sub-Saharan Africa, we help clients expand into new markets. Our services are fully adaptable to suit country-specific requirements, ensuring smooth registration and compliance.

Why Choose DI Regulatory Consultants?

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Cost-effective solutions

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Comprehensive regulatory expertise

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Detail orientated

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Up to date with the latest regulatory requirements

Partner with DI Regulatory Consultants — your go-to consultant for the pharmaceutical industry in South Africa.