Regulatory
Compliance Services and Strategies
Our unique approach
As with all our work, we pursue a holistic approach to all regulatory audits, striking a balance that is compliant with the pertinent legislation while supporting the desired marketplace position of the product.
Our toolkit
1. Natural Health Products PLA's (Product License Applications) and NPN (Natural Product Numbers)
Our pre-market submissions to the NGP Directorate are thorough, accurate and well-written, leading to faster response times and earlier launch dates.2. Gluten free foods
Since 1995, manufacturers in the USA, Canada and the EU have benefited from our skills and knowledge in this area. We are regarded by the food industry and healthcare professionals as well, as foremost experts in the composition and labelling of gluten-free foods.3. Health Canada Novel Food Submissions, Novel Dietary Fibre Submissions and Health Claims on Food Submissions:
Novel Food Pre-market Notifications:
We prepare, write and submit Novel Food Pre-market Notifications to Health Canada on behalf of several clients. Health Canada approved Novel Foods are listed here; applications for some have been prepared by us:
http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index_e.html
Novel Food Applications are comprehensive scientific documents, which must adhere to the following Health Canada Guidelines, available for viewing at:
http://www.hc-sc.gc.ca/fn-an/gmf-agm/pol/index_e.html
Novel Dietary Fibre Applications:
We have 15 years' experience in submitting Novel Fibre applications to Health Canada. Our comprehensive approach includes securing the clinical and scientific data outlined in Health Canada's Guidelines
http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/novel_fibre_nouvelle_app-ann2_e.html, and preparing a high-calibre submission that meets Health Canada's requirements. Some Novel Dietary Fibres approved following submissions prepared by us are listed within CFIA Novel Dietary Fibre Table 6-12 at the following link:
http://www.inspection.gc.ca/english/fssa/labeti/guide/ch6ae.shtml#6.8
Health Claims on Foods
is one of Health Canada's newest guidance documents, which we were engaged to implement and submit to Health Canada in support of a health claim on a bioactive ingredient, the month following its March 2009 publication:
http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/health-claims_guidance-orientation
_allegations-sante-eng.php
4. Animal Feed Supplements and Veterinary Drugs Pre-market Notifications
Our Growing expertise in acquiring regulatory compliance for several marketplace applications of bioactives now includes pre-market notifications pertaining to animal feed supplements and veterinary drugs.5. Audit & Remedial Services:
| - Food Labels | - Websites | - Advertising |
Our Seal of Approval covers:
* Label audits and reviews sales sheets, advertising and websites
* Compliance in defined geographical markets (e.g. USA, Canada)
* Compliance of proposed claims and statements
* Identification of overlooked claims
* Nutrition Facts Table scrutiny
* Accurate provision of mandatory and voluntary information
* Reviews of educational, research-based promotional material
6. Regulatory Impact Studies:
Several organizations -- both private and public -- call on us to understand and assess the effect of regulations on specific market place activity, some of which include:-
Canadian
International Trade Tribunal
- Canadian Agricultural Policy Institute
- Agriculture and Agri-Food Canada
Release of final report pending AAFC approval
- Canadian Agricultural Policy Institute
- Agriculture and Agri-Food Canada
Release of final report pending AAFC approval
7. Participation in
Government-agency led Consultations in
Canada and the 
US :
Since the inception of
our company 15 years ago, we have participated
in several Government-agency consultations, the more recent of which
are highlighted below.(1)
Canada:
- Health Claims Consultation
- Health Canada: Proposed Policy: Definition and Energy Value for Dietary Fibre
- Health Canada: Dietary Sodium Reduction Strategy
- Pre-market Notification Submissions
- Canada's Food Guide Revision
- Whole Wheat and Whole Grain Discussion
(2) USA:
- Gluten-free Labelling of Foods
- Health Claims Consultation
- Health Canada: Proposed Policy: Definition and Energy Value for Dietary Fibre
- Health Canada: Dietary Sodium Reduction Strategy
- Pre-market Notification Submissions
- Canada's Food Guide Revision
- Whole Wheat and Whole Grain Discussion
(2) USA:
- Gluten-free Labelling of Foods
8. Courses and Seminars
Want to acquire hands-on learning? Attend one of our bi-annual full-day courses, sponsored by the Guelph Food Technology Centre: click here for course details.
