Regulatory Compliance Shouldn’t Feel Like a Battlefield.
Let Ex–US FDA Regulatory Experts Guide You From Product Concept to Global Market Approval.
At Afpharma Consulting™, we help pharmaceutical, medical device, food, dietary supplement, and cosmetic manufacturers navigate US FDA, EU CE Marking, ISO 13485, NAFDAC, Ghana FDA, Kenya PPB, Rwanda FDA, SFDA, TMDA, Zimbabwe MCAZ, and other global regulatory systems without delays, sleepless nights, or rejected applications.
Why Companies Choose Afpharma Consulting™
Nigerian-based Ex–FDA & Ex–NAFDAC regulatory experts
Multi-country approval expertise (USA, Nigeria, Ghana, Kenya, Rwanda, Tanzania, South Africa, Zimbabwe)
Structured compliance framework for predictable approvals
99.4% client satisfaction rate
Audit-ready documentation and compliant processes
Afpharma Consulting™ ensures your submissions meet global regulatory expectations accurately, quickly, and professionally
WHO WE ARE
Ex–US FDA Regulatory Specialists Serving Africa & Global Markets
Afpharma Consulting™ is a Nigerian-based regulatory consulting firm led by former FDA regulatory officers, quality auditors, scientific reviewers, and compliance analysts.
We support manufacturers and distributors seeking:
US FDA approval
NAFDAC registration
CE Marking
ISO 13485 certification
Multi-country regulatory compliance
Our Compliance Framework
Our proven 5-step approach delivers clarity and reliable outcomes:
Product Evaluation & Gap Audit
Regulatory Strategy & Approval Mapping
Technical Documentation & Dossier Preparation
Submission & Regulatory Liaison
Certification Support & Team Training
We make complex regulatory requirements simple, structured, and achievable.
SERVICES
US FDA, NAFDAC & Global Product Registration
Regulatory support for:
Pharmaceuticals
Medical devices
Dietary supplements
Foods & beverages
Cosmetics
Herbal & traditional medicines
Includes:
Dossier development, compliance review, submission management, and end to end liaison with regulatory bodies.
ISO 13485 & Quality Management Systems
We help medical device companies implement and maintain:
ISO 13485
ISO 9001
GMP systems
Technical File documentation
CE Marking compliance
Audits, Reviews & Corrective Actions
Internal compliance audits
QMS audits
Documentation review
CAPA system setup
Facility compliance checks
Regulatory Training & Capacity Development
Customized training for:
FDA/NAFDAC submission requirements
Quality documentation
Audit readiness
GMP & GDP compliance
Labeling, Packaging & Claims Compliance
Ensure all product labels, claims, inserts, and packaging comply with FDA, NAFDAC, and global standards.
FAQ
Do you support companies outside the U.S.?
Yes. We serve clients across Africa, the U.S., Asia, and international markets.
How long does FDA or NAFDAC approval take?
Timelines vary by product and agency.
We provide accurate timelines after a Gap Audit.
Do you guarantee approval?
No firm can guarantee approval.
However, we offer the Afpharma Compliance Assurance:
If rejection occurs due to an oversight on our part, we reprocess your submission free of charge.
Can Afpharma manage full regulatory submissions?
Yes. We handle everything from strategy to documentation, submission, follow-up, and audit responses.
What product categories do you work with?
Pharma, medical devices, cosmetics, supplements, food/beverage, herbal, and biomedical companies.
Do you provide training?
Yes. We offer compliance workshops and QMS training for regulatory and quality teams.
Move From Uncertainty to Full Compliance.
Partner With Ex–US FDA Experts.
Afpharma Consulting™, Your Global Regulatory Advantage.