We are Regulatory Affairs consultants with many years of industry experience and ready to help you achieve your goals.
We offer the following range of services, please contact us with any questions you may have.
Regulatory Strategy & Business Development
Strategic advice and support for your international business expansion plans. We have obtained marketing authorizations and conducted due diligence activities in many markets and can help you develop a sound strategy for your business development goals.
Develop and/or advise on a Health and Nutrition communication strategy for your products domestically and internationally.
Guidance on designing clinical studies to substantiate label claims.
Product portfolio review. We conduct a review of your product portfolio and provide an assessment which will provide valuable market/category insights e.g. label claims, as well as regulatory recommendations based on the current and future policy landscape.
Regulatory Affairs and Compliance
Review of ingredients (excipients, actives, etc.) for acceptability/suitability of use in foods and dietary supplements for the US, Canada, European Union and other international markets.
Review and/or preparation of Label Copy and Labeling. We help you ensure your Food and Dietary Supplements labels comply with the applicable regulations in the intended market by providing advice on all the mandatory elements on a label including declaration of ingredients, nutrition/supplement facts, cautionary statements, disclaimers, etc.
Formulation guidance for Food & Dietary Supplements products for US and International markets. Our substantial experience domestically and internationally helps us provide you with sound advice to help you develop a product that will be compliant with the relevant regulations in more than just one market so you can optimize your development efforts.
Regulatory review and guidance for substantiation of claims made on labeling and advertising materials. We review and offer suggestions on the claims you intend to make on a product to help you effectively deliver your message to the consumer while meeting statutory and regulatory requirements.
Scientific and Regulatory support for development and substantiation of product claims. Our team can develop and/or help you develop the required scientific support for product label claims.
Review and advice of structure/function claims and preparation of Dietary Supplements 30-day notifications for submission to US FDA.
Regulatory Policy & Intelligence
Regulatory Intelligence services and strategic advice on a variety of domestic and international issues affecting the Food, Dietary Supplements and Pharmaceutical Industries including Regulatory Policy issues, Scientific, Clinical, Food Safety, Health & Nutrition, etc.
We provide ongoing Regulatory Intelligence monitoring; interpreting and reporting on the regulatory and policy landscape.
Interpretation of and advice of the impact and opportunities that new and proposed rulings, regulations and policies from FDA, EFSA, EMA and other relevant domestic and international authorities may have on current practices.
Delivery of robust intelligence relevant to client’s specific business via periodic intelligence alerts/newsletters, reports and summaries of key regulatory developments, meetings, etc.
Targeted Regulatory Intelligence research, gathering and analysis of topics, areas, or regions of interest to the client.
We provide training for staff on essential knowledge of Regulatory Intelligence and Policy tools and resources and how these can be helpful in their activities.
Representation of clients in trade association and other industry or Health Authority meetings.