Services

Defined scopes for FDA market-entry work.

Each engagement starts with product category, sales channel, available records, and compliance objective.

Foreign establishments

FDA US Agent

For foreign facilities that need a US point of contact for FDA correspondence.

Cosmetics

Facility registration and product listing preparation support for cosmetic brands.

Labels and claims

Review of required label elements, claim language, allergen statements, and category-specific risk points.

Marketplace risk

Review of titles, bullets, images, product pages, and claims that can create FDA-related marketplace risk.

Medical devices

Initial classification, predicate research, and submission-readiness planning.