Practice & Operating Standard
How we structure regulatory engagements, the practitioners leading the dossiers, and the rigorous principles that define our track record in Kenya and East Africa.
Dossiers, deadlines, and technical depth
We work in rigorous dossiers and committed deadlines. Every engagement begins with an exhaustive gap analysis against active Pharmacy and Poisons Board CTD guidelines, followed by a time-bound filing plan.
Pre-Submission CTD Audits: Complete module-by-module compliance audit before submission fees are incurred.
Live Document Register: Transparent status tracking covering every query, document iteration, and milestone date.
Active Regulatory Representation: Direct technical liaison with committee evaluators during formal board sittings.
Five modules, audited before a fee is paid
- RegionalM1
- SummariesM2
- QualityM3
- NonclinicalM4
- ClinicalM5
How we protect your timelines
The operational tenets that distinguish our advisory work from generic forwarding agencies.
No Blind Forwarding
Every regulatory query from the Pharmacy and Poisons Board is thoroughly analyzed with recommended solutions and draft responses before reaching your desk.
Accountable Named Leads
Engagements are led by qualified regulatory pharmacists with deep therapeutic category experience, not passed down to junior account handlers.
Financing & HTA Synergy
We connect market authorization directly to Social Health Authority (SHA) and BPTAP reimbursement pathways so products become commercially funded.
EAC Regional Harmonisation
Submissions are architected to leverage Kenyan approvals for mutual recognition and joint assessments across Uganda, Tanzania, and Rwanda.
Named leads with verifiable credentials, specialized therapeutic experience, and in-country regulatory accountability.
The people who do the work
Start with a confidential dossier gap audit
Submit your active CTD files or product profiles for an objective feasibility assessment, timeline projection, and regulatory roadmap.