Nautilus Pharma

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Nautilus Pharma

Contact

Location

Lavender Lane, Kuilsriver,
Cape Town, 7580,
South Africa

Our Services

Regulation & Compliance

Nautilus Pharma Regulation

Our Services

Regulation & Compliance

Tap into our regulatory expertise with our specialised team. Let’s navigate the complex legal landscape of together.

Regulations

Our Services

From concept to completion, we offer complete solutions.

Product Development

Quality Control

Quality Control

Quality Assurance

Quality Assurance

Manufacturing

Manufacturing

Blending Innovation with
Rigorous Regulatory Compliance

The Nautilus Pharma Regulatory Affairs team comprises of two pharmacists and a pharmacist assistant, collectively offering over two decades of regulatory experience to the company. Their expertise spans the legal requirements for foods, complementary medicines (CMs) and nutraceuticals.

 

Since the inclusion of category A and D medicines (CMs) under the Medicines Act (Act 101 of 1965) in November 2013, the team has cultivated extensive knowledge of the complementary medicines regulatory landscape in South Africa. To maintain currency with category D (CMs) requirements, the team engages in continuous review of new legislation and guidelines and maintains membership with the Health Products Association of South Africa (HPASA).

The Regulatory Affairs team’s proficiency encompasses various aspects of the product development process and beyond, including:

 

  1. Product development and formulation
  2. Labelling, including the authoring of professional information (PI) and patient information leaflets (PIL)
  3. Sales and marketing material compliance
  4. Quality assurance and control, including material and product testing requirements
  5. Pharmacovigilance
  6. Regulatory intelligence and impact assessment
Regulations

Nautilus Pharma holds a license to manufacture medicines, including category D (CMs), and maintains an active listing in the South African Health Products Regulatory Authority (SAHPRA) online register for category D (CMs) licenses with a 3D Product Listing.

We extend our regulatory and technical capabilities to customers by offering to act as an applicant on their behalf, leveraging our expertise to navigate the complex regulatory environment.

Nautilus Pharma’s expertise provides our clients with a high degree of confidence in regulatory compliance and product integrity, enhancing their reputation in the industry and supporting their continued growth in the competitive sector.