Supplements - NHPs

Whether they are referred to as dietary or food supplements, natural health products, or complementary medicines, one thing is clear: with the increasing availability of such products regulatory authorities are demanding greater standards of evidence to ensure that the public has access to products that are safe, effective, and of high quality.

The regulation of supplement products differs around the world, with some jurisdictions considering these products as foods, and others as drugs. The types of health claims and accompanying standards of evidence differ, with structure-function claims permitted in certain countries, and treatment and disease reduction claims allowed in others. In addition, some regulatory frameworks have a review process for supplement ingredients, while others only consider the licensing of finished products. Standards for good manufacturing practice to ensure quality also differ, with some countries requiring the inspection and licensing of facilities involved in the manufacture of finished products.

With the differing pre-market requirements and ever-changing regulatory landscape, developing a well thought-out strategy is key to identifying the most efficient route to market and becoming an industry leader.

Our services include:

• Conducting feasibility assessments and providing recommendations to meet regulatory requirements for safety, efficacy, and quality;
• Compiling technical and scientific submissions to regulatory authorities, including new dietary ingredient notifications, product license applications, ingredient master files, and complementary medicines applications;
• Providing product development support;
• Assisting in the design, placement, monitoring, and management of clinical trial protocols for claim substantiation;
• Preparing expert opinion letters;
• Acting as a liaison with regulatory authorities during the submission review process; and
• Administering programs to meet post-market requirements, including adverse event reporting, regulatory monitoring, and surveillance programs.