Documentation
Regulatory Dossier Preparation
Fee: Request a quote
Every market’s registrations and notifications call for specific information and documents about the product. Examples include the product information file (PIF) and safety report for cosmetics in the EU and the UK, the 510(k) submission for medical devices in the US, the importer’s FSVP file for food, and process filings for low-acid canned food.
Who Is Obligated?
Manufacturers that will register or notify in one or more markets.
What We Do
- We determine the dossier contents required for your product and target markets.
- We gather formula, manufacturing, testing and label information in a single dossier.
- We organize the dossier in the structure the market requires and keep it up to date.
What You Receive
- Regulatory dossier per product
- List of missing documents
Regulatory Dossier Preparation Application
Target market, product type, purpose of the dossier and the data you have so we can prepare the registration or notification dossier your product needs.
Frequently Asked Questions
- Why is a regulatory dossier needed?
- Every market’s registrations and notifications call for specific information and documents about the product. Keeping this information organized in a single dossier lets you provide the requested documents quickly, during registration and afterward.
- Which dossiers does this service cover?
- For example, the product information file (PIF) and safety report for cosmetics in the EU and the UK, the 510(k) submission for medical devices in the US, the importer’s FSVP file for food, and process filings for low-acid canned food. We determine at the outset which contents are required for your product and target markets.
- What information do you need from us?
- Formula, manufacturing, testing and label information. We let you know which documents you do not have with a list of missing documents.
- If we sell the same product in more than one market, do we need separate dossiers?
- Most of the information is shared, but each market requires the dossier in its own structure. We gather the information in one place, organize the dossier in the structure each market requires and keep it up to date.
Sources: Kozmetik Tüzüğü (AT) 1223/2009, Md. 10 ve 11; GOV.UK: Making cosmetic products available in Great Britain; 21 CFR 807.87; 21 CFR 1.502; 21 CFR 108.35.