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Pharos Health

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Regulatory Affairs - Pharos Health

At Pharos Health, we are the beacon Guiding & Elevating Corporate & Institutional Wellness, Compliance, Pharmaceutical Excellence, and Universal HealthCare access across East Africa. 

Whether you're navigating pharmaceutical quality & regulatory compliance, improving employee well-being, or ensuring the consistent delivery of quality medicines, we’re here to support you every step of the way. At Pharos Health, we don’t just meet standards—we raise the bar. Let’s build a future where your people thrive, your systems excel, and your health investments go further.

Transforming regulatory complexity into strategic necessity

At Pharos Health, our ambition is to transform regulatory complexity into a strategic necessity and simplicity for decision-makers. With deep local insight and regional expertise, we help clients navigate fragmented frameworks, shifting requirements, and diverse market dynamics – streamlining the path to compliance and accelerating access across Africa and other emerging markets.

We specialize in the registration, advisory, licensing, and listing  of the following product types:

Pharmaceutical Medicines

Medical Devices & IVDs

Complementary Medicines

Borderline products

Services

Licensing and Compliance:

  • Licence applications, amendments, and renewals
  • Establishment and guidance on Quality Management Systems (including SOPs, Site Master Files, and Quality Manuals)
  • GxP compliance support
  • Audit readiness and preparation
  • Regulatory due diligence and acquisition advisory
  • Guidance on product- and licence-specific conformity requirements (e.g., ISO certification)
  • Acting as the Marketing Authorisation Holder on behalf of manufacturers for the East African and surrounding markets

Regulatory Services:

  • Regulatory advisory on local requirements, harmonization efforts, product and country strategy, advertising, and medical claims
  • Product classification tailored to each country’s regulatory framework
  • Due diligence / Gap Analysis on registration dossiers for NCEs, generics, biologicals, and biosimilars
  • Dossier compilation and preparation for new product registrations
  • Ongoing lifecycle management of active and dormant products (variations, renewals, and updates)
  • Compilation and review of Professional Information, including SmPCs, Patient Information Leaflets, labels, and artwork
  • Preparation and publishing of documentation in eCTD format using DocuBridge
  • Advisory and support for Clinical Trial applications and regulatory submissions

Regulatory Intelligence

  • In-depth regulatory intelligence for specific African markets, covering local requirements and processes
  • Insights across the product lifecycle, including clinical trials, registration, and post-registration activities
  • Strategic in-country connections provide accurate, current intelligence and guidance for effective market expansion

Translation Services

  • Translation of SmPCs, Patient Information Leaflets, labels, artwork, and promotional material
  • Services available in English, Swahili and French, ensuring compliance and clarity across markets