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.
- Comprehensive insights across the product lifecycle, including clinical trials, registration, and post-registration activities.
- Strategic in-country connections that provide accurate, up-to-date intelligence and guidance for effective market expansion.
Translation Services
- Translation of SmPCs, patient information leaflets, labels, artwork, and promotional materials.
- Services available in English, Swahili, and French, ensuring compliance and clarity across markets.