Health Canada Consultants

Health Canada Consultants

Focal Point Research is a highly experienced Regulatory Affairs & Quality Assurance Consulting Firm. We have long been considered a leader in scientific and regulatory compliance across many industries and we maintain that reputation by remaining current with regulations and forecast changes that are expected. Whether you are creating a new product, or enhancing an existing one, we have the know-how to get your product to market.

 

Focal Point Research offers the following
Health Canada Consulting Services

Cosmetic Consulting
  • Review Labels, Inserts, and Advertising for Canadian Compliance
  • Review ingredients forCanadian compliance with our proprietary software
  • Prepare and Submit Health Canada Cosmetic Notifications
  • Design and commission product testing, clinical trials to establish claim support and product compatibly
  • Provide regulatory support for products refused entry by Canadian Customs and/or Health Canada inspectors
Natural Health Product (NHP) Consulting
  • Review Labels, Inserts, and Advertising for Canadian Compliance
  • Review ingredients for compliance with our proprietary software
  • Prepare and submit Product License Applications
  • Importation of Natural Health Products to Canada
  • Setup and implementation of NHP GMP Quality Assurance System
Drug Consulting
  • Review Labels, Inserts, and Advertising for Canadian Compliance
  • Review ingredients for compliance with our proprietary software
  • Prepare and submit applications to Health Canada for approval; DIN, CTA, NDS, ANDS
  • Drug Establishment License Approvals
  • Setup and implementation of Drug GMP Quality Management System
Medical Device Consulting
  • Label Reviews and Classification of Products, Class I to IV
  • Prepare and Submit Applications for Class II, III or IV
  • Obtain and maintain Medical Device Establishment Licenses
  • Host Health Canada MDEL Inspections
Medical Affairs and Adverse Effect Reporting
  • Preparation of medical documents for healthcare professionals
  • Analysis of adverse events for cosmetics, drugs, devices and supplements
Consumer Product Consulting
  • Review packaging and labelling for regulatory compliance
  • Evaluate consumer complaints and manufacturing quality systems
Packaging Development Consulting
  • Development of primary, secondary and tertiary packaging components
  • Label development, including review of labelling requirements for the Canadian market
  • Shelf life testing of package and product interactions using both analytical and sensory evaluation

“Focal Point Research has consistently and professionally looked after regulatory and quality issues of our brand for years. Through a courteous and knowledgeable team, they have managed to navigate us through an ever changing regulatory landscape while maintaining our interests, and allowed us to correctly distribute and sell within Canada.”

“I have truly enjoyed working with you over the last 8 years! You and your team have been an amazing resource for me. I have always been impressed by the knowledge and professionalism of everyone at Focal Point, which is a true testament to your leadership.”

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The Focal Point Research team is ready to help with all of your scientific and regulatory needs.  Our team has the experience and expertise you need to see your product to market and we are eager to help you.