Automate repetitive tasks and reduce risk.
From the U.S. FDA and Health Canada to EU/UK cosmetics regulations,
COMVALIS, proven through 1,000+ projects, supports your company’s export compliance.
COMPLIANCE YOU CAN RELY ON
YOUR COMPLIANCE PARTNER, COMVALIS
Automate repetitive tasks and reduce risk. From the U.S. FDA and Health Canada to EU/UK cosmetics regulations, COMVALIS, proven through 1,000+ projects, supports your company’s export compliance.
01
ABOUT
FROM COMPLIANCE TO QUALITY ASSURANCE
Since 2017, COMVALIS has successfully completed approximately 1,000 regulatory approval projects. Beyond regulatory support, we also provide GMP consulting and validation services, systematically strengthening our clients’ manufacturing quality competitiveness.
Since 2017, COMVALIS has successfully completed approximately 1,000 regulatory approval projects. Beyond regulatory support, we also provide GMP consulting and validation services, systematically strengthening our clients’ manufacturing quality competitiveness.
From the U.S. FDA and Health Canada to EU and UK cosmetics,
COMVALIS, proven through 1,000+ projects, is your trusted partner for global growth.
02
SERVICE
From the U.S. FDA and Health Canada to EU and UK cosmetics, COMVALIS, proven through 1,000+ projects, is your trusted partner for global growth.
FOOD
We provide regulatory support for the U.S. and Canadian markets, including ingredient and labeling standards review, registration, and label compliance services.
COSMETICS
We provide support for U.S. and Canadian cosmetic ingredient and regulatory requirements review, as well as registration, labeling, and claims review services.
ANIMAL FOOD
We provide support for U.S. and Canadian animal food regulatory requirements, including ingredient review, registration, and label compliance services.
OTC DRUG & NHP
We provide support for monograph review for exports to the U.S. and Canada, as well as U.S. FDA listing, Health Canada licensing, and label compliance services.
MEDICAL DEVICES
We support medical device classification, registration/listing, testing, and the preparation of validation documentation.
LASER RADIATION PRODUCTS
From preparing the CDRH laser Product Report to submission and ongoing maintenance, we provide end-to-end support.
AI LABELING COMPLIANCE
We support greater efficiency in labeling operations through automated Nutrition Facts calculation and image generation. (Upcoming services: Drug Facts and AI labeling compliance for cosmetics)
cGMP & VALIDATION
We provide gap analysis, USP-based test method development, SOP preparation, process and cleaning validation, and method verification/validation protocol development.
U.S. AGENT
We provide U.S. Agent designation, operation of the FDA point of contact, notification handling, and ongoing registration maintenance services, including renewals and updates.
Automate U.S. and Canadian food and cosmetic labeling—without the manual effort. Boost operational speed with an automation solution trained on regulatory data
FOOD
We provide regulatory support for the U.S. and Canadian markets, including ingredient and labeling standards review, registration, and label compliance services.
COSMETICS
We provide support for U.S. and Canadian cosmetic ingredient and regulatory requirements review, as well as registration, labeling, and claims review services.
ANIMAL FOOD
We provide support for U.S. and Canadian animal food regulatory requirements, including ingredient review, registration, and label compliance services.
OTC DRUG & NHP
We provide support for monograph review for exports to the U.S. and Canada, as well as U.S. FDA listing, Health Canada licensing, and label compliance services.
MEDICAL DEVICES
We support medical device classification, registration/listing, testing, and the preparation of validation documentation.
LASER RADIATION PRODUCTS
From preparing the CDRH laser Product Report to submission and ongoing maintenance, we provide end-to-end support.
AI LABELING COMPLIANCE
We support greater efficiency in labeling operations through automated Nutrition Facts calculation and image generation. (Upcoming services: Drug Facts and AI labeling compliance for cosmetics)
cGMP & VALIDATION
We provide gap analysis, USP-based test method development, SOP preparation, process and cleaning validation, and method verification/validation protocol development.
U.S. AGENT
We provide U.S. Agent designation, operation of the FDA point of contact, notification handling, and ongoing registration maintenance services, including renewals and updates.
Automate U.S. and Canadian food and cosmetic labeling—without the manual effort.
Boost operational speed with an automation solution trained on regulatory data
REGULATORY COMPLIANCE AND VALIDATION
A Lasting Partnership
Driven by Value
From the U.S. FDA and Health Canada to EU CPNP and UK SCPN,
COMVALIS delivers integrated regulatory compliance and quality system solutions for global export success.
REGULATORY COMPLIANCE AND VALIDATION
A Lasting Partnership Driven by Value
From the U.S. FDA and Health Canada to EU CPNP and UK SCPN, COMVALIS delivers integrated regulatory compliance and quality system solutions for global export success.
03
CONTACT
SEND US A MESSAGE
Send us your inquiry, and we will respond as soon as possible.
COMPANY : COMVALIS CORP I CEO : SEUNGHOON BAEK TEL : 031-8029-9377 I FAX : 031-624-4807 IMAIL : comvalis@comvalis.com BUSINESS LICENSE : 339-87-00684 I ADD : Room 615, Hyundai Techtree, 150 Dongtan-daero, Hwaseong-si, Gyeonggi-do, Korea
ⓒ 2026 COMVALIS. ALL RIGHTS RESERVED.
COMPANY : COMVALIS CORP I CEO : SEUNGHOON BAEK TEL : 031-8029-9377 I FAX : 031-624-4807 MAIL : comvalis@comvalis.com BUSINESS LICENSE : 339-87-00684 ADD : Room 615, Hyundai Techtree, 150 Dongtan-daero, Hwaseong-si, Gyeonggi-do, Korea
