US market work is done here at a published price. EU and UK filings legally need a Responsible Person established in market, so we coordinate those through a partner and quote them per product.
INCI accuracy · required warnings · drug-claim risk
Compiling the dossier, not holding it
Cosmetics Direct portal submission prep · SPL format
The Responsible Person must be legally established in the EU or UK and carry liability insurance for that role, and Part B of a CPSR must be signed by a credentialed assessor. We do not claim either. We line up the partner, hand over your dossier, and stay your point of contact.
Available via our regulatory partner network. Request a quote.
Three common situations, priced from the menu above. Every number comes from the catalog.
A single SKU sold only in the United States. The label needs checking and the facility and product need MoCRA paperwork prepared.
Filing in Cosmetics Direct is yours to submit; we prepare it. No FDA fee applies.
A small line with a label review, a Product Information File and MoCRA prep for each product. The Full Compliance Bundle prices all three services together, per product.
Bought separately the same three services come to $1,200 per product.
One product headed for the US and the EU. US work is done here at the listed prices. The EU Responsible Person, CPSR and notification go through our partner and are quoted per product.
EU and UK Responsible Person, CPSR and notification: partner cost plus our coordination fee, quoted after the form below.
No, and we say so on every stability page. Stability studies run under monitored in-house environmental conditions, which is real data for shelf-life and development decisions but is not ISO 17025 certified data. Microbial testing and EU/UK filings are run by certified third parties and coordinated by us.
Study length is fixed by the program you buy, for example three months of accelerated stability or twelve months at room temperature. In-house stability reports are delivered within 10 business days after the study ends. Regulatory-prep deliverables arrive within 10 business days of receiving your complete inputs. Micro panels and EU or UK filings carry the partner lab's stated turnaround, which we pass through and confirm on your invoice.
Pick your services in the shop, check out as a guest with your email and shipping details, and you get a sample submission checklist by email. Formulation projects and EU or UK compliance start with a short form instead, because both are scoped before they are priced.
