Services

Regulatory Services

Full-range regulatory services for cosmetics, food and beverage, dietary supplements and pharmaceuticals.
Heuer M.D. provides a full range of regulatory services for the cosmetic, food and beverage, dietary supplement and pharmaceutical industries. Our consultants 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.

Status

Currently Recruiting

Interested in this study? Reach out to our Orlando research team for a prescreening conversation.

Study interest form

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Submissions are handled securely by the Heuer M.D. Research team.

Cosmetics

FDA / FTC / ASRC representation

U.S. FDA Form 483 and warning letter analysis and response

Review labels, websites and advertising claims

Clinical trial design to substantiate product label claims

USDA and border ingredient importation issues

GMP / GCP / GLP audits (domestic and international)

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

Label, website and advertising claim review

Clinical trial design to substantiate product label claims

White papers and monographs

NDI notifications and GRAS submissions

Adverse event monitoring and reporting

Health Canada PLA and NPN applications

USDA and border ingredient importation issues

DSHEA and NHPD compliance

GMP / GLP / GCP audits (domestic and international)

Identity testing and toxicology reporting

Food and Beverage

FDA / FTC / ASRC representation

U.S. FDA Form 483 and warning letter analysis and response

Review of labels, websites and advertising claims

Clinical studies designed to substantiate label claims

GRAS dossiers and submissions

GMP / GCP / GLP audits (domestic and international)

USDA and border ingredient importation issues

Adverse event monitoring and reporting

Identity testing and toxicology reporting

Speak with the Orlando research team

Ask about currently recruiting studies, eligibility or what participation involves. Every conversation is voluntary and private.