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COSMEREG: Regulatory Experts for Cosmetics, Food, Supplements & Medical Devices
We assist Cosmetic, Food, Medical Devices and, Drug companies to be compliant with local regulations in the US, Canadian, and European markets.
Regulatory services by product category
FDA food facility registration, acidified and low-acid food process filing (SID), labelling and FSVP.
Classification, claims and labelling under US DSHEA, Canada NHP (NPN) licensing and Dubai registration.
Class I to III classification, FDA establishment registration, Health Canada MDL and Dubai registration.
Technical files, Declarations of Conformity and gap assessments under Regulation (EU) 2025/40.
OUR SERVICES
US AGENT AND EU/UK/Canada Responsible Person
Any foreign company wishing to enter the U.S. market for certain product categories must appoint a U.S. Agent. For cosmetic products intended to be sold in the UK, Europe, and Canada, it is mandatory to designate a Responsible Person.
COSMETICS – OTC
Cosmereg can help from classifying Cosmetic or OTC products and register them accordingly the FDA and Health Canada regulations. Support with product submission to the VCPR for US and CNF for Canada.
FOOD AND BEVERAGE
Cosmereg provides complete assistance for food and beverage companies to be compliant with the FDA and Canadian Normative and help with facility registration, Process Filing for Acidified and Low-Acid Canned Foods (SID), food labeling review, and FSVP related services.
DIETARY SUPPLEMENTS
Both the US and Canada market have their regulations regarding dietary and Natural Health product. Cosmereg help to complete the steps to assess marketing claims, product classification to be compliant.
MEDICAL DEVICES
We offer regulatory compliance services for medical devices of Class I and Class II and III for the US and Canada. Our team can classify your product, prepare and submit your medical device registration, and ensure a successful launch.
DRUGS
We offer a full service to guide your company through the FDA drug approval process. All establishments that are involved in the production, development, packing or storage of products that are classed as drugs in the U.S. are required to register with the FDA.
WHY YOU SHOULD work WITH US
Your local representative in the US, EU, UK and Canada
Foreign companies need a US Agent for FDA and a Responsible Person for cosmetics in the EU, UK and Canada. Cosmereg acts in that role through its US, Irish and UK entities, with the dossier work handled by the same team.
FDA US Agent
Cosmetics (MoCRA), food, drugs and medical devices
EU Responsible Person
Regulation (EC) No 1223/2009, CPNP notification
UK Responsible Person
UK Cosmetics Regulation, SCPN notification
Canada Responsible Person
Cosmetic Notification Form (CNF), bilingual labelling
More than
We help client with regulatory services
Total
WHAT OUR CLIENTS SAY
Don’t just take our words for it. Our clients are our biggest supporters. Would you like to know what they think about us?
What our clients say
Don’t just take our word for it. Here is what brands and manufacturers say about working with Cosmereg.
“We enjoyed the professionalism of the Cosmereg team in handling the label compliance of our cosmetic products and the registration process for the US market.”
“Ten years working with Cosmereg on our food safety compliance. They are reliable and able to clear authority enquiries when necessary.”
“Entering the EU cosmetics market was a complex task for a new company like ours, but in Cosmereg we found a partner to guide us through the full process successfully. We are happy to continue our collaboration.”
“Experts in their field. They obtained the NHP licence for our supplement within the timeline, and we will continue working with them on more products from our range.”
Global reach beyond our five regions
Through a network of trusted local partners we coordinate product registrations in further markets, with Cosmereg as your single point of contact and the same dossier behind every submission.
- Latin & Central America
- Saudi Arabia
- India
- China
- Japan
- South Korea
- Australia
- New Zealand
- ASEAN
Cosmereg offices and core regions Partner markets
CONTACT US TODAY TO GET STARTED.
The sooner you get in touch with Cosmereg, the sooner you can introduce your products to the world.
PARTNER’S NETWORK
We also count with a network of partners around the world to cover registration process in other markets like:
- Latin and Central America
- United Arab Emirates
- Saudi Arabia
- India
- China
- Japan
- Korea
- Australia
- New Zeland
- ASEAN
An active member of leading cosmetic industry associations:
