Helping you meet regulatory and scientific requirements with clarity and confidence.
Scientific and Regulatory Advisory Services
Strategic guidance and hands on regulatory support that helps you meet scientific and compliance requirements across African countries.
Regulatory Strategy and Planning
We guide you through each step needed to obtain approval for your product.
This includes:
- Classification assessment
- Identification of the regulatory pathway for single or multi country projects
- Country requirement mapping with detailed timelines
- Scientific and technical gap analysis
- Label and claim review prior to registration
- Preparation of regulatory intelligence reports for local, regional, or continental plans
Dossier Preparation and Regulatory Submissions
We prepare, compile, and submit compliant dossiers that meet national authority expectations.
This includes:
CTD, eCTD compilation
Support with data organization and document formatting
Review for completeness and accuracy
Submission through electronic portals or physical channels
Response management for authority queries
Variations, renewals, and lifecycle maintenance
Labeling and artwork compliance review
Compliance Support
We help you maintain regulatory alignment after approval.
This includes:
Guidance on GMP, GDP, and GCP expectations
Support during audits or inspections
Development of standard operating procedures
Review of quality documentation
Safety and quality documentation preparation
Local authority communication for compliance requirements
Clinical Trial Regulatory Support
We support regulatory and ethics steps needed for clinical trials in Africa.
This includes:
Protocol regulatory review
Ethics committee submissions
Ministry of Health approvals
Preparation of site regulatory documents
Import permits for investigational products
Safety reporting during clinical research
Coordination with authorities through each regulatory milestone
Local Technical Representation
We act as your designated in country technical contact where required by law.
This includes:
Managing all regulatory communications
Supporting market authorization holder responsibilities
Handling product variations, recalls, and safety escalations
Maintaining compliance throughout the product lifecycle
Import and Export Permit Processing
We support movement of regulated products across borders.
This includes:
Import permit applications
Export permit processing
Document verification
Coordination with customs and national authorities
Tracking and follow up until completion
Get In Touch With Us
Ready to navigate regulatory pathways or strengthen product safety, contact our team for expert support and tailored solutions.