Regulatory Compliance Pricing
Transparent pricing for product registration, dossier preparation, and ongoing compliance management with the Pharmacy and Poisons Board.
Choose Your Service Tier
From new drug registrations to ongoing compliance monitoring, select the package that fits your regulatory needs.
New Drug Registration
Bundled per-product service fee
Timeline: 6-12 months (PPB-dependent)
Bundle includes
- Initial dossier evaluation & CTD compilation
- Submission to PPB
- One standard round of query-response handling
- Local Technical Representative (LTR) representation - for foreign applicants
- Labelling & artwork review
Add-ons
Paid separately by client
- PPB registration feeUSD 1,000 / product
- NQCL sample testingAt cost
- GMP inspection (if required)At cost
Dossier Registration
Product dossier compilation & submission
Timeline: 2-4 months
- Product dossier compilation
- Quality, safety & efficacy documentation
- PPB submission management
- Query response handling
- Approval follow-up
Ongoing Compliance Monitoring
Continuous regulatory support
Ongoing retainer
- Regulatory change tracking
- Product renewal management
- Variation submissions
- PPB correspondence handling
- Compliance status reporting
- Monthly advisory sessions
What's Included Across All Tiers
Every regulatory compliance engagement includes these essential components.
Who Is This For?
Our regulatory compliance services are designed for businesses navigating Kenya's pharmaceutical regulatory landscape.
Pharmaceutical Importers
Pharmaceutical importers registering products for the Kenyan market who need expert guidance through the PPB submission process.
Drug Manufacturers
Manufacturers launching new drug products in Kenya & East Africa who require complete CTD dossier preparation and regulatory strategy.
Compliance Outsourcing
Companies needing ongoing regulatory compliance management without in-house expertise, seeking a reliable external compliance partner.
Frequently Asked Questions
What is the New Drug Registration process in Kenya?
The PPB requires a complete dossier submission in CTD format including quality, safety, and efficacy data. We handle the entire process from dossier preparation through approval, including responding to PPB queries.
How long does drug registration typically take?
PPB processing typically takes 3-12 months depending on product category and dossier completeness. Our expertise ensures submissions are right first time, minimizing delays.
Can you handle registrations for multiple products?
Yes, we offer volume discounts for batch registrations. Contact us for custom pricing on 5+ product registrations.
Do you handle product renewals and variations?
Yes, our ongoing compliance monitoring package covers renewals (every 5 years), variations (formulation changes, manufacturer changes, etc.), and all PPB correspondence.
Start Your Registration Process
Get expert regulatory guidance from our team. We'll help you navigate the PPB submission process from start to finish.
Free initial consultation included - No obligation - Same-day response