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onyx pharma is a South African based omni-channel company specializing in pharmaceutical solutions. We are driven to make an impact in the healthcare sector through partnerships, regulatory services, and strategic expert advice. 
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Our business value proposition is centered around 3 pillars:

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REGULATORY &  COMPLIANCE
  • Regulatory submissions: Preparing and submitting documents to health authorities.
  • Compliance audits: Ensuring adherence to regulatory standards.
  • Labelling and packaging review: Meeting regulatory requirements.
  • Advertising and promotion reviews: Ensuring compliance of all materials with regulatory standards.
  • Regulatory consulting: Providing expert advice on strategies and pathways.
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PARTNERSHIPS & COLLABORATION
  • Importation: We source products, design innovative formulations, and match local and international manufacturers to client needs.
  • Exportation: We service Sub-Saharan Africa, providing comprehensive support for exporting pharmaceutical products.
  • Section 21 Solutions: We offer specialized solutions for the importation and use of unregistered medicines in exceptional circumstances.
  • Contract Manufacturing: Partnering with manufacturers to produce high-quality pharmaceutical products, ensuring adherence to GMP.
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CUSTOMER CENTRICITY
  • Meeting customer expectations: We complete projects on budget and on time, meeting customer expectations.
  • Putting the patient first: Our solutions always prioritize the needs and well-being of patients.
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Onyx Pharma takes pride in its commitment to social and economic transformation, proudly holding a B-BBEE Level 1 status. This not only underscores the company's dedication to inclusivity and empowerment but also assures compliance with South Africa's Broad-Based Black Economic Empowerment policies.
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Fulfilling unmet needs in the Healthcare sector by developing and strengthening partnerships, offering Regulatory solutions, and expanding access to quality medicines.
Fulfilling unmet needs in the Healthcare sector by developing and strengthening partnerships, offering Regulatory solutions, and expanding access to quality medicines.
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Onyx Pharma is led by Managing Director and Responsible Pharmacist Jeremy Hudsonberg.

With over 17 years of industry experience, Jeremy has held key roles in leading multinational and generic pharmaceutical companies in South Africa. He brings extensive technical, managerial, commercial, and strategic expertise to the table. Known for his solutions-driven approach, Jeremy leverages his broad-based cross-functional network to consistently deliver projects on time and within budget.
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With the increasing pressure of regulators, compliance and public interest in the pharmaceutical industry, onyx pharma is positioned with critical capabilities to support any size pharmaceutical business with strategic solutions through its regulatory knowledge and risk protocols. Our focus is strategic, solution-driven, quality services that meet our clients’ needs, every time.

onyx pharma leads with integrity and upholds the Medicines Act and Regulations, SAHPRA requirements, and follows the spirit of the Marketing Code Authority in South Africa. 

onyx pharma services the private and state market. Due to our vision of addressing unmet needs, the foundation of the company is built on partnerships with those who share a common goal of providing access to quality medication to the broader population of South Africa. At onyx pharma we understand the need for collaborative partnerships to effectively drive patient outcomes.
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Due to our principle of addressing unmet needs, the foundation of onyx pharma is built on partnerships with those who share a common goal for providing access to quality medication to the broader population of South Africa and neighboring countries.
 
If you require our services, or if you are interested in partnering, connect with us:
EMAIL: info@onyxpharma.co.za 
CONTACT: +27 72 288 3396
onyx pharma only partners with GMP (Good Manufacturing Practice) approved manufacturers.

All contact points will be reacted to within 48 hours.
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The Role of Artificial Intelligence in Revolutionizing Pharma

Artificial Intelligence (AI) is reshaping the pharmaceutical industry, driving innovation and efficiency across various domains. From drug discovery to patient care, AI is becoming an indispensable tool for pharma companies aiming to stay competitive in a rapidly evolving landscape.


One of the most transformative applications of AI is in drug discovery. AI algorithms can analyse vast datasets to identify potential drug candidates, significantly reducing the time and cost associated with traditional methods. For example, generative AI is now being used to design molecules and predict their behaviour, accelerating the development of new treatments.


AI is also revolutionizing clinical trials. By leveraging predictive analytics, pharma companies can optimize trial designs, select suitable participants, and monitor outcomes more effectively. This not only improves the accuracy of trials but also ensures faster regulatory approvals.


In addition, AI is enhancing operational efficiencies within the industry. Automated systems powered by AI can manage supply chains, forecast demand, and streamline manufacturing processes. These advancements help companies reduce waste and improve productivity.


Moreover, AI is playing a crucial role in patient care. From personalized medicine to automated disease detection, AI-driven tools are enabling healthcare providers to offer more precise and timely interventions.


As AI continues to evolve, ethical considerations and regulatory frameworks will be essential to ensure its responsible use. The integration of AI in pharma is not just a technological shift; it's a paradigm change that promises to improve healthcare outcomes globally.

References
2. Artificial Intelligence in Pharma: What 2025 Holds for Us
3. Transforming Pharma Marketing with AI: The Complete Guide for 2025
1 AUGUST 2024
Phenylephrine lack of effectiveness of oral preparations as nasal decongestant

The document addresses the lack of effectiveness of orally administered phenylephrine as a nasal decongestant based on discussions and recommendations from the United States Food and Drug Administration (US-FDA) and the Advisory Clinical Committee.

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November/December 2024
Documents* out for comments:

  1. SAHPGL-MD-16 - Guidelines on Clinical Evaluation of Medical Devices
  2. SAHPGL-MD-17 - Guideline on Clinical Investigation of Medical Devices
  3. SAHPGL-MD-18 - Post Market Surveillance and Post-market Clinical Follow-up Studies
  4. GLF-MD-17A - Application for Clinical Investigation of Medical Devices

Published: 18 November 2024

Submission deadline: 20 December 2024 by 4PM

Submit to: mdreg@sahpra.org.za


* For full information on these documents please 

Click here