Precision in Healthcare.Confidence in Regulation.
We deliver regulatory and compliance expertise across Kenya and Africa's healthcare sector—ensuring safety, quality standards, and faster market access for innovators and care providers.
Services That Define Excellence
From regulatory foresight to post-approval optimization, our services are designed to guide healthcare organizations through every stage of the product journey with confidence.
Strategic Regulatory Intelligence
Anticipate policy changes and emerging requirements with data-driven insights that support smarter decision-making.
- Predictive analytics
- Risk assessment
- Opportunity mapping
Accelerated Submission Excellence
Precision documentation and proactive agency engagement to cut approval timelines and reduce costly delays.
- eCTD mastery
- Real-time tracking
- Agency liaison
Global Market Access
Coordinated strategies and localized expertise that simplify expansion into multiple jurisdictions.
- Harmonized dossiers
- Local expertise
- Fast-track pathways
Compliance Innovation
Modern quality frameworks and digital tools that keep you inspection-ready and adaptable to evolving standards.
- GxP excellence
- Audit readiness
- Digital QMS
Lifecycle Optimization
Sustaining long-term product value through continuous monitoring, label enhancements, and strategic portfolio support.
- Label expansion
- Patent extension
- Value maximization
Specialized Therapeutics
Tailored regulatory pathways for advanced treatments, including rare diseases and next-generation therapies.
- Rare disease focus
- Cell & gene therapy
- Expedited programs
Why Partners Choose Ultra Pharma
Clear advantages you'll feel from day one. Practical systems, local know-how, and delivery models built to move healthcare products forward in Kenya and across Africa.
Outcome-Driven Submissions
We build dossiers around approval triggers: pre-submission audits, agency-ready narratives, and checklist-driven gap closure.
Fewer questions from regulators, shorter review cycles.
Rapid-Response Regulatory Unit
A dedicated team that activates for urgent filings, regulatory queries, or inspection support — available to jumpstart time-critical matters.
Reduces stoppages and protects launch windows.
Local Architects, Regional Reach
In-country specialists translate global standards into locally acceptable strategies, coordinating with partners and stakeholders on the ground.
Smoother market entry with fewer reworks.
Compliance-by-Design
Quality systems, SOPs, and traceable records are integrated from the outset—digital-first, audit-ready, and scalable.
Inspection resilience and lower remediation costs over the product lifecycle.
Client-Aligned Commercial Models
Choose what works: milestone fees, retainer+milestone hybrids, or outcome-linked engagements tailored to project risk.
Aligns incentives and reduces upfront budget friction.
Capacity & Knowledge Transfer
Practical workshops, SOP handovers, and on-the-job mentoring so your team gains autonomy fast.
Long-term capability, less reliance on external support.
Get In Touch
Connect with our regulatory team for guidance, proposals, or rapid-response support.
Contact Information
Address
Nairobi, Kenya
Phone
+254 020 5618353LinkedIn
Connect with us