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Safeguarding Health Through Regulatory Excellence

We act as the strategic bridge between pharmaceutical companies and regulatory authorities in Africa, ensuring uncompromising compliance and patient safety.

Certified QPPV
PPB Recognized
Aksumia Global Certified

Our Expertise

Strategic Regulatory Solutions

We deliver uncompromising compliance and safety management services, allowing you to focus on advancing healthcare.

Pharmacovigilance System Master Files (PSMF)

Comprehensive authoring, maintenance, and strategic review of your PSMF to guarantee continuous regulatory compliance.

Environmental Risk Assessments (ERA)

Expert evaluation of pharmaceutical impact, ensuring your products meet all environmental regulatory guidelines.

Product Stability & Climate Strategy

Rigorous climate zone stability testing strategies tailored for the diverse African pharmaceutical market.

QPPV Outsourcing

Dedicated Qualified Persons for Pharmacovigilance to oversee your safety systems with unmatched local expertise.

Core Values

The VIGIL Code

Our guiding principles define how we bridge the gap between pharmaceutical innovation and stringent regulatory compliance.

V

Value-Driven

We deliver measurable regulatory value through precision and foresight.

I

Integrity

Uncompromising ethical standards in all compliance frameworks.

G

Global Health

Committed to the One Health approach, safeguarding human and environmental well-being.

I

Integration

True partnership and integration with your internal teams and external agencies.

L

Leading Agility

Rapid adaptation to shifting African regulatory landscapes.

Our Team

Experts in Compliance

Backed by years of regulatory and clinical experience across the African continent.

Dr. Emily Mochama

Compliance Strategy Lead

Dr. Emily Mochama

Founder & CEO | B.Pharm|Msc. One Health

Leading compliance strategy with a deep focus on One Health and pharmaceutical regulations across Africa.

Dr. Faith Makokha
Dr. Faith Makokha

Clinical Affairs Specialist | B.Pharm

Driving clinical trial compliance and post-market surveillance strategies.

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Sam Barongo
Sam Barongo

Legal Counsel | LLB

Navigating complex regulatory frameworks and pharmaceutical law.

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Stephen Ogoti
Stephen Ogoti

Quality Assurance Manager

Ensuring absolute adherence to international QMS and compliance standards.

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Sam Bennyhim
Sam Bennyhim

Operational Lead | MBChB

Expert in pharmacovigilance technology systems and regulatory submission pathways.

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Get In Touch

Partner With Us

Ready to streamline your regulatory journey across Africa? Schedule a compliance audit or send us a direct message below.

Contact Information

Whether you need a full-scale pharmacovigilance system setup or targeted regulatory submissions, our team is ready to assist.

Email Us

info@vigilaxsummit.com

Call Us

+254 (0) 700 000 000

Headquarters

Nairobi, Kenya Serving the entire African continent.

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