Our Nigerian team is made up of qualified, trained and experienced Regulatory Affairs and business management professionals. We provide you with quality compliance services that include regualtory affairs, quality, importation and related on-going business management services.
Our Local Authorized Representative Sevice protects you against loss of proprietry information to commercial distributor(s), allows you to select your commercial distributors with flexibility of multiple commercial distributors and enables shorter/flexible distribution contract term that is shorter than 5 years.
NAFDAC Regulatory Submissions and Approval for Drugs (Rx and OTC), Herbal Products, Medical Devices and Cosmetics;
- Submission package, product label preparation, guidance and review
- Regulatory submission follow-up and facilitation
- NAFDAC meeting or inspection representation
- Post-Approval changes management
Local Authorized Representative Service (Nigeria);
- Retention and maintenance of regulatory and distribution records (including proprietary information)
- Products Post-approval management and representation with regulatory authorities
- Pharmacovigilance/Product vigilance activities and record maintenance services
- Coordination and preparation of importation/shipment clearing activities with commercial distributors
- Technical/Scientific representation at meetings, detailing and exhibition events
GMP/Quality System services for Importation and Manufacturing Facilities. This includes but not limited to;
- Establishing new international standard GMP facility - importation or manufacturting
- Preparation for & Representation at Foreign regualtory inspection (EU, Health Canada & US FDA Audit)
- Vendor Auditing & Periodic Self-Inspection
- QA Product release services
- Validation & Stability studies Consulting services - ICH standard/specifications
- API GMP compliance services
- Creation & revision of SOP
- GMP & SOP Training
Complete Product Vigilance Services (Pre-& Post Approval Vigilance for Drugs & Medical Devices);
- Complaint receiving and product information Contact Center services
- Setting-up a new or updating existing PV?
- Preparation of SOPs and related records required for effective PV management
- Literature Search, Signal detection Medical Reviews & Annual Summary reports preparation
- PV System Personnel training for effective system management
- 2nd Party audit; performance of periodic PV Self-inspection
- Medical Device Complaint & Problem Reporting System Set-up and Management
Feel free to contact us with your request for review and quote.