Reliable and Responsive Regulatory Consulting

Services

From initial development to final production.


PRODUCT DOCUMENTATION

Develops collaborative supplier and raw material qualification processes. Supports the design of IT systems for management of regulatory product profiles and automation of basic technical documentation including Specifications, Ingredient Statements, Ingredient Breakdowns, Nutritionals, SDS and labels.  


SUBJECT MATTER RESOURCE AND MENTOR

Do you already have a regulatory team that is interested in growing their knowledge of global food, feed, drug and cosmetic regulations.  Food Regulatory Guild routinely develops audience appropriate materials to educate external (eg. Suppliers, Customers, Distributors) and internal (eg. Customer Service, Sales, Chemists, Manufacturing) personnel on relevant regulations. Verbal presentations and written communications are clear, informative, and geared toward the audience's needs.


PACKAGING COMPLIANCE

Although there are clear guidelines governing many aspects of labeling, each product is unique and therefore product labeling requires various considerations including the target audience, industry best practices as well as relevant government regulatory actions.


US/INT REGULATORY ASSESSMENT

Interprets regulations of >80 Countries. Has a global view and is comfortable and effective working with global partners. Understands global markets and international considerations. Works directly and/or indirectly with global government agencies governing food, feed, drugs and cosmetics including the US FDA, USDA, US TTB, PRC MOH, Japan MOH, KFDA, EFSA, EU DG SANTE, Health Canada, ANZFA, ANVISA, JECFA and CODEX.


PRODUCT DEVELOPMENT AND OPTIMIZATION FOR GLOBAL MARKETS

Collaborates on multi-disciplinary teams to successfully bring a product from concept to commercialization. Works with R&D teams to optimize formulations to meet global market regulatory criteria and trends. Then works with marketing to assure compliant labeling.


DEVELOPING STANDARD OPERATING PROCEDURES

Need help developing a quality manual, standard operating procedures (SOPs) and/or informal company position statements to address Product Formulation, Supply Chain Controls, Good Manufacturing Practices (GMPs), Labeling, Sustainability, Country of Origin (CoO), Religious Qualification/Certification, Vegan/Vegetarian Diets, Genetically Modified Organisms (GMO’s), Allergens, Organic Compliance/Certification, Livestock Diseases (BSE, END, FMD), Rework, Respiratory Hazards, Proposition 65, GHS SDS, REACH, CLP, DOJ Regulated Materials and more…?

 

Are you ready?