Regulatory Submissions
Our Comprehensive Approach to Regulatory Compliance
We evaluate regulatory compliance using rigor and discipline, helping you identify potential issues and collaborating to develop appropriate solutions.
FDA facility registration
The Food & Drug Administration requires organizations supplying food or drugs to consumers to register their manufacturing facilities.
We can help you complete the registration process quickly so you can focus on running your company.
TTB analysis and submissions for alcoholic beverages
We will gather appropriate documentation needed, and prepare applicable web forms for proper flavor submissions to the TTB Nonbeverage Products Lab (NPL)
BE (Bio-Engineered) labeling standard set up and review
We review your raw materials to ensure that proper labeling information is presented to customers if you sell B2B or consumer packaging for retail brands.
Certifications
- USDA organic certification
- Kosher certification
Responses
- Warning letters
- Product holds or recalls
- Allergen warnings
Cosmetic ingredient review
We can review your formulas, along with contact suppliers if necessary, for applicable documentation, against regulatory agency guidelines
FDA claims
- Natural and organic food
- Structure/function
- Nutrient content
- Food additives
We know keeping up with today’s rapidly evolving regulatory affairs and compliance guidelines can be daunting. When you create an alliance with us, you’ll have a partner who helps you navigate challenges and sets your company up for long-term success.
Let us be your resource to address regulatory issues with tested industry and implementation experience. Contact us today!