877.912.4622

"Over the years, BIO-CAT has had the good fortune to hire excellent people to run our operation."

- Ed Schuler

Regulatory

The Regulatory Department at BIO-CAT provides our customers with regulation review and assistance, product and consumer safety information, import/export support, and other ad hoc services. Specifically, the services include the provision of documentation to customers to support their regulatory compliance files:

  • GRAS Statements
  • Allergen Statements
  • Certificates of Origin
  • Animal Derivative, BSE/TSE Statements
  • Composition Statements
  • GMO Statements
  • HALAL certification; as issued under Islamic Laws by the Islamic Food and Nutrition Council of America (IFANCA®)
  • Kosher Status certification; as issued by the Kashruth Division of the Orthodox Union (OU)
  • Harmonized Tariff Schedule
  • Irradiation/Ionization Statement
  • Melamine Statements
  • Nutritional Statements
  • Organic Statements
  • Vegetarian/Vegan Statements
  • Safety Data Sheets

 

BIO-CAT supports our customers with registration processes to relevant regulatory bodies. Regulatory authorities that we have worked with recently include the Canadian Health Authorities, OMRI, Environmental Protection Agency and TGA. Additionally, we have experience in managing clinical trials with the generation of Good Clinical Practice Technical Agreements as per ICH Q6 R1 both for BIO-CAT and our customers where needed.

The Regulatory team at BIO-CAT works closely with various industry groups such as the Enzyme Technical Association (ETA), the American Feed Industry Association (AFIA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), to name a few.