Regulatory Compliance
Know what applies to you — and prove it.
- Requirements assessment
- Product registration and submissions
- Regulatory gap assessments
- Licensing support
- Dossier preparation
Regulatory · Quality · Compliance
From requirement to compliance excellence.
Consulting for pharmaceutical, healthcare and regulated manufacturing across East Africa.
- 7
- Stages, assessment to improvement
- 6
- Service lines
- 3
- Engagement levels
- 100%
- Independent
01Areas of focus
Four disciplines. One outcome.
Quality Management Systems
Make quality repeatable, not personality-dependent.
- QMS development
- SOP development
- Quality manuals and policies
- CAPA systems
- Change control
Pharmaceutical Quality & GMP
Measured against what an inspector will apply.
- GMP compliance assessment
- GMP gap analysis
- Pharmaceutical quality systems
- Validation and qualification
- QC laboratory systems
Operational Excellence
Compliance that also makes the process better.
- Process performance improvement
- KPI development
- Continuous improvement
- Quality by design
- Root-cause analysis
02How we work
Assessment to compliance excellence
Seven stages. Every engagement.
Scroll the pathway →
Independent
No ties to any manufacturer, supplier or regulator.
Objective advice, or it is worth nothing.
03Services
All servicesSix service lines
010203040506
Regulatory Affairs
Assessment, submissions, registration and ongoing compliance.
Requirements assessment · Product registration and submissions · Dossier preparation and review · Licensing and permit support
Quality Management Systems
SOPs, CAPA, deviations, change control and risk management.
Quality manual and policy · SOPs and work instructions · CAPA and deviation systems · Change and document control
GMP & GxP Compliance
GMP, GDP and GSP assessments. Inspection readiness.
GMP assessment and gap analysis · GDP and GSP assessments · Validation and qualification support · Supplier qualification
Quality Control & Laboratory Systems
QC systems, analytical quality and laboratory compliance.
QC system design · Analytical quality and method control · Data integrity review · Instrument qualification support
Training & Capacity Building
GMP, QMS, regulatory affairs, QA/QC and risk management.
GMP and GxP awareness training · QMS and SOP training · Regulatory affairs fundamentals · QA/QC technical training
Operational Excellence
Lean and Six Sigma. Root-cause analysis. KPIs.
Process performance assessment · Root-cause analysis (DMAIC) · Quality KPI development · Continuous improvement programmes
04Engagement
Assess. Implement. Maintain.
Level 1
Assessment
“Where are you now?”
An independent picture of your regulatory and quality position, ranked by risk.
- Requirements review
- GMP and QMS gap assessment
- Readiness audits
- Prioritised findings report
Level 2
Implementation
“How do you become compliant?”
We build and install what the assessment found — documents, systems, training and support.
- SOP and QMS development
- CAPA and documentation
- Personnel training
- Hands-on implementation
Level 3
Maintenance
“How do you stay compliant?”
A standing relationship that keeps you current as regulations and your operation change.
- Periodic audits
- Regulatory updates
- KPI monitoring
- Inspection readiness
05Who we serve
Regulated industry
Pharmaceutical & Healthcare
Where regulatory expectation is highest.
- International pharmaceutical companies
- Local manufacturers
- Importers
- Wholesalers and distributors
- Pharmacies
- Hospitals and health institutions
- Medical-device companies
- Diagnostic and laboratory companies
- Clinical research organisations
Other Regulated Manufacturing
Where quality systems and process discipline transfer.
- Cosmetics manufacturers
- Food and beverage
- Nutraceuticals
- Personal care
- Chemical manufacturers
- Consumer healthcare
- Medical consumables
For non-pharmaceutical clients our strength is quality systems, regulatory compliance and risk management; sector-specific technical requirements are supported through qualified subject-matter experts.
JC
Jean Claude MANIRARORA
Founder & Principal Consultant
06Who we are
Pharmacy, quality science and Six Sigma in one practice
Pharmacist · MSc Pharmaceutical Sciences (QC & QA) · Six Sigma Black Belt
A pharmacy degree for product and healthcare knowledge, an MSc in pharmaceutical quality science for the technical foundation, and a Six Sigma Black Belt for process improvement.
That combination is why our engagements do not stop at telling you what the regulation says.
- 01
- BPharm — Bachelor of Pharmacy
- 02
- MSc Pharmaceutical Sciences (QC & QA)
- 03
- Six Sigma Black Belt
07Values
What we stand for
01
Integrity
Honest assessments. Every report, every time.
02
Excellence
Benchmarked against international best practice.
03
Client Partnership
Partners, not vendors.
04
Continuous Improvement
We build the discipline we teach.
05
Professionalism
Evidence-based, confidential, on time.
06
Collaboration
Compliance is built together, not imposed.
Start here
Find out where your gaps are.
One short conversation is usually enough to tell.