Heuer M.D. provides a full range of regulatory services for the cosmetic, food and beverage, dietary supplement and pharmaceutical industries. Our consultants can assist your business to ensure compliance with government regulations. Their extensive experience provides the expertise to help your business comprehend the FDA, FTC and other regulatory requirements for cosmetics, food and beverages, dietary supplements and pharmaceuticals.
COSMETICS
- FDA / FTC / ASRC representation
- U.S. FDA Form 483 and warning letter analysis and response
- Review labels, websites and advertising claims for compliance with FDA and FTC
- Clinical trial design to substantiate product label claims
- USDA and border ingredient importation issues
- Conduct site GMP / GCP / GLP audits domestically and internationally
- Adverse event monitoring and reporting
- Identity testing and toxicology reporting
- Risk assessments and risk mitigation strategies
Dietary Supplements
- FDA / FTC / NARC representation
- U.S. FDA Form 483 and warning letter analysis and response
- Review dietary supplement labels, websites and advertising claims for compliance with FDA and FTC
- Clinical trial design to substantiate product label claims
- White Papers and Monographs
- New Dietary Ingredient Notifications and Generally Recognized As Safe submissions
- Adverse event monitoring and reporting
- Health Canada PLA and NPN applications
- USDA and border ingredient importation issues
- DSHEA and NHPD Compliance
- Conduct Site GMP / GLP / GCP audits domestically and internationally
- Identity testing and toxicology reporting
- Risk assessments and risk mitigation strategies
Food and Bevarage
- FDA / FTC / ASRC representation
- U.S. FDA Form 483 and warning letter analysis and response
- Review labels, websites and advertising claims for compliance with FDA and FTC
- Design clinical studies to substantiate label claims
- GRAS dossiers and submissions
- Conduct Site GMP / GCP / GLP audits domestically and internationally
- USDA and border ingredient importation issues
- Adverse event monitoring and reporting
- Identity testing and toxicology reporting
Departments
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Heuer M.D. Research
We are a medical research center dedicated to the advancement of medical knowledge for current and future medical treatments . We are committed to the importance of clinical trial research and clinical trial participation and promoting the positive contribution they provide to society.
Why choose our clinic
Led by an internationally accomplished medical research physician, our study center is dedicated to the advancement of medical knowledge for current and future medical treatments.
Key Industries Served:
- Pharmaceutical
- Dietary Supplements
- Food and Beverage
- Cosmetic and Personal Care
Regulatory Services:
- Pharmaceutical
- Cosmetics
- Dietary Supplements
- Food and Beverage