Our Services

Specialist services across the pharmaceutical lifecycle

From first registration to post-market surveillance, we cover the full spectrum of regulatory, quality, pharmacovigilance, and training needs.

Every engagement is delivered by practicing pharmacists who know both the science and the regulations.

We coverPharmaceuticalsMedical devicesCosmeticsBiotechNutraceuticals

Pharmacovigilance

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

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

Powered byPvSentinel

Our pharmacovigilance compliance platform for MAHs and LTRs. Case intake, periodic reports, AI-assisted literature and signal detection, and a complete PV system with document management and PSMF.

Learn more about PvSentinel

Drug 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 Rep 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

Supply Chain Support & Quality Assurance

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

GSDP compliance audits
GDP-compliant quality management systems
Supply-chain risk management plans
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 new African markets, 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
Communication, negotiation, and collaboration workshops
Time, project, and meeting-facilitation training
Job interview and exit interview support

Why outsource

Focus on your core. Leave the compliance to us.

Reduced operational costs
Access to specialised expertise
Faster time-to-market, 30% faster registrations on average
Internal resources focused on core competencies
Shared risk and business continuity

Ready to raise your compliance to global standards?

Partner with a pan-African team that embeds the expertise you need to protect market access and grow with confidence.

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