Navigating Health Canada, FDA, and global markets since 2007. 3,500+ companies. 74 countries. 60,000+ projects. Quality Smart Solutions is a diversified global consulting firm assisting clients worldwide primarily in the areas of regulatory compliance, quality assurance research and development, project management and business process improvement. Quality Smart Solutions has helped a diverse portfolio of clients, from start-up companies to billion dollar corporations reach their goals and help build their product portfolio. Vision:
To be a global leading advisor to consumer health product companies and be a symbol of excellence in regulatory compliance solutions. What differentiates us from the competition:
Fast turnaround time for submissions (in less than a month to submit if all conditions met), exceptional customer service and competitively priced. Our service and personal touch approach have brought about many happy clients who have had no hesitation to referred to other organizations. Services:
CANADA SOLUTIONS:
Product License Application (NPN) for Natural Health Products (NHP)
Veterinary Health Product Registration (NN)
Cosmetic Label compliance and notification submission
Food label compliance and French translation
Temporary Market Authorization Licence (TMAL) for supplemented foods
OTC Drug registration and label compliance (DIN)
Medical Device Registration (MDL) for class 2,3,4
Site License Application
Site License Renewal
Drug Establishment Licence (DEL)
Medical Device licence (MDEL)
Standard Operating Procedure writing
HACCP or P*P Food Safety Plan implementation
Importer of Record (Quality IMPORT Solutions) for NHPs
Food Importer into Canada (SFCR licensed food importer)
On-Site or remote audit
Complaint handling management
Adverse Event Reaction handling
International Regulatory Assistance (Mexico, Europe, UK, Australia)
Clinical Research support
Translation services
Artwork Design conversion solution
USA SERVICES:
Dietary Supplement Label compliance
Dietary Supplement facility registration
Food label compliance
Food facility registration
Cosmetic Label compliance
OTC Drug registration (NDC)
OTC Drug Facility Registration
510(k) medical device licence registration
Medical Device Facility registration
US Agent services
HACCP and P*P food safety plan setup
FSVP Agent service
Generally Regarded as Safe (GRAS) self attestation or FDA notice
