Fixed prices, per product
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.
Label & Claims Review (US or EU rules)
INCI accuracy · required warnings · drug-claim risk
Included
- INCI accuracy checked against your formula sheet
- Required warnings and label elements for the target market
- Marketing language checked for US drug reclassification risk
- Claims checked for EU substantiation risk
- Written findings with the wording changes to make
Not included
- Signed safety assessment, CPSR Part B
- Artwork or packaging design production
- Legal advice
- Filing with any authority
Product Information File (PIF) Assembly
Compiling the dossier, not holding it
Included
- Product description and manufacturing method compiled
- GMP statement assembled
- Claim substantiation collected into the file
- Stability and microbial data filed in
- A complete dossier handed to you
Not included
- Holding the file as your Responsible Person
- The signed CPSR Part B
- EU or UK notification
- Liability for the underlying test results
US MoCRA Facility Registration + Product Listing Prep
Cosmetics Direct portal submission prep · SPL format
Included
- Facility registration prepared
- Product listing prepared
- Content formatted for Cosmetics Direct in SPL format
- A submission-ready package with your responsible person details
Not included
- US Agent duties
- Label design
- Ongoing listing updates after submission
- Adverse event reporting on your behalf
EU and UK
EU/UK Responsible Person + CPSR + notification
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.
Before you buy
Is Skin By K.Lynn an accredited lab?
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.
What are your turnaround times?
Study length is fixed by the program you buy, for example three months of accelerated stability or twelve months at room temperature. Reporting time after the study ends, and turnaround on micro panels and regulatory work, is confirmed in writing when your samples or files arrive.
How do I place an order?
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.