Specialist services across the pharmaceutical lifecycle

Pharmacovigilance

Compliant safety systems that protect patients and satisfy regulators, run by qualified persons.

We combine global pharmacovigilance standards with deep-native expertise in Kenya's Pharmacy and Poisons Board regulatory environment, enabling pharmaceutical companies to achieve compliance, certainty, and strategic advantage while championing patient safety.

• QPPV and back-up QPPV provision
• PV system establishment and compliance
• Case processing and management
• Continuous literature screening
• Signal detection and risk management
• PV agreements and vendor oversight
• Regulatory intelligence and submissions
• PV system audits, internal and vendor
• PV training for staff, reps, and distributors
• Crisis communication and safety issue management

Regulatory Affairs

We navigate Africa's regulatory landscape end to end, keeping your products compliant and your pipeline moving.

• Dossier pre-screening for completeness
• Dossier submission
• Product retention, variation, and renewals
• Listing of medical devices
• Labelling and artwork review and approval
• GMP applications
• Regulatory intelligence
• Clinical trial applications
• Special pathways: reliance, emergency and compassionate use
• Premise registration and distribution licensing

Medical Sales Team Training

Technical training that sharpens your reps' credibility with prescribers.

• Sales training for medical reps
• Product detailing and positioning
• Reviewing key clinical studies
• Proactive and reactive medical information
• CME presentations

Marketing Support

Scientifically sound, regulator-ready marketing for your commercial teams.

• Product monograph development
• Design and regulatory review of promotional items
• Application for advertisement approvals
• Training sales teams on scientific messaging
• Development and delivery of CME programs
• Regulatory review of patient-facing digital and print

GSDP and QMS Compliance

We take the headache out of quality across your distribution network.

• GSDP compliance audits
• GDP-compliant quality management systems
• Internal audits
• Supplier and vendor audits and monitoring
• Quality agreements with supply-chain partners
• Full support during regulatory inspections
• Import permits, customs clearance, and duty exemptions
• Deviation, OOS, and complaint investigations
• GxP training programs for personnel
• Batch release training for qualified persons
• Pre-qualification programs for procurement

Market Access Program Support

A structured path into the Kenyan market, from eligibility to implementation.

• Market research on eligibility and infrastructure
• Competitor analysis and market intelligence
• Stakeholder assessment and engagement
• Market entry and operational model development
• Regulatory pathways and approval
• Stakeholder onboarding
• Program implementation

Local Technical Representative (LTR)

We become your technical representative in Kenya, so you can focus on your core business.

• Regulatory representation and legal agency
• Product registration management
• Local pharmacovigilance services
• Import processing and batch release coordination
• Regulatory intelligence and compliance monitoring
• Recall and market action execution
• Documentation and license maintenance
• Stakeholder communication

Other Registration Services

The additional registrations that protect and list your products.

• Trademark registrations
• Product registration at KEBS

Staff Personal Development

Practical training that builds capable, confident technical teams.

• Leadership training for managers and team leaders
• Team-building and motivation sessions
• Financial literacy and personal finance
• Programs for new and emerging leaders
• Coaching in strategy and cross-functional influence
• Time, project, and meeting-facilitation training
• Job interview and exit interview support