Despite the probiotic industry’s fast-paced growth and promising market potential—the segment is expected to reach $52 billion by 20201—companies face three major challenges when developing probiotics: ensuring stability, characterizing products, and substantiating health claims.
At Nutrasource, we understand that probiotics are a unique category unlike any other in the dietary supplement realm. We offer full solutions to support your probiotic market launch strategy with the highest quality results.
Our regulatory consulting and clinical trials teams will help you understand potential regulatory barriers and how to overcome them confidently. We will help you design and execute your clinical trials in a timely manner while determining suitability of single versus multi-centre trials while balancing your budgetary needs.
To gain pre-market approval in Canada, we can assist clients with preparing and submitting NHP Product Licence Applications (PLAs). For the U.S. market, we can also assist with preparing and submitting Generally Recognized as Safe (GRAS) and New Dietary Ingredient Notifications (NDIN) filings to help verify the safety of probiotics and gain regulatory compliance.
Nutrasource is an active member of the International Probiotics Association (IPA) and was the first North American CRO to join the organization. We currently have seats on IPA’s Board of Directors and our staff are active participants on IPA committees. Members of our scientific team have hosted educational workshops and given lectures to pass along our expertise in clinical research and regulatory compliance for probiotics at IPA industry events, including SupplySide West and Probiota. Our involvement with IPA provides our team with the opportunity to have an impartial voice in the probiotics community. Our access to the latest research, regulatory changes, and market trends ultimately benefits our clients as they bring probiotics to market in the U.S., Canada, and the EU.
Explore our regulatory and clinical services for probiotics:
- Product Development Strategy
- Clinical Trials
- Compliance Consulting
- Health Claims Substantiation
- Product Classification
- Technical Label Review
- Natural Health Product (NHP) Licensing
- Nutrition Facts Panel Review
- Dietary Supplement Facts Panel Review
- Scientific Literature Reviews
- Generally Recognized as Safe (GRAS)
- New Dietary Ingredient Notifications (NDIN)
- Natural Health Product (NHP) Site Licensing
- Drug Establishment Licensing
- New Drug Submissions (NDS) and New Drug Applications (NDA)
- Abbreviated New Drug Submissions (ANDS) and Abbreviated New Drug Applications (ANDA)
Our product testing services for probiotics include:
Learn how we can help you overcome your research and regulatory challenges to successfully commercialize your probiotic.
Clinical Trials Roadmap: A Go-To-Market Guide for Probiotics
Discover tips and strategies for developing a successful clinical trials program for probiotics.
Managing Risk in Probiotic Stability
Learn how to properly handle and store probiotics during a clinical trial so their efficacy is not compromised