Reg-Affairs Services

Our Services

Dedicated to taken care of your regualtory and quality concerns, we provide a buffet of services that covers regulatory and quality management needs in the entire life-cycle of various healthcare products. Our key objective is to swiftly take your products to the market and successfully sustain their compliance.

$ Request for Quote

We offer the best services in:

Regulatory compliance services that cover the complete life-cycle of the following healthcare products in Canada, EU, US & Nigeria;

Prescription & OTC Drug Products
Medical Devices
Natural Health /Herbal Products (only in Canada & Nigeria)
Cosmetic Products
Low Risk Veterinary Health Products (LRVHP - Canada only)

Quality compliance services that include establishment and on-going management of;

Drug GMP; for Distribution, Importation and Manufacturing Facilities
Natural Health Products GMP; for Importation and Manufacturing Facilities
Medical Device QMS (ISO 13485, CMDCAS ISO 13485 & MDSAP); for Virtual Manufacturers and Fabricators
Complete Product Vigilance Services (Pre-& Post Approval for Drugs, Devices & LRVHP); include contact center services

Local Authorized Representative Service in Nigeria 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. This service includes;

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

Clinical Trial Management Services for drug products and medical devices;

Study Design and Protocol writing and review
CTA/IND and ITA/IDE Application preparation and submission with Health Canada and FDA
Study Data Analysis and Report writing/review for regulatory submission
Study Adverse Event management and reporting
Study site monitoring and auditing

Our Trade-Link Gateway is a special resource that is designed to facilitate market entry for new products.

Your One-Stop Solution to Healthcare Products Regulatory Compliance!