Artixio

Regulatory Affairs Services for Cosmetics Industry

Bringing your cosmetic products to global markets starts with the right regulatory approach. Artixio offers cosmetics products consulting services for regulatory affairs—covering everything from claim review to dossier preparation and day-to-day compliance support.

Regulatory Affairs Services Consultant for Cosmetics Industry

Regulatory affairs approval process for cosmetics products can be tricky to navigate without the right guidance. At Artixio, we support global cosmetic brands with regulatory insight that’s grounded, timely, and aligned with local expectations. Whether you are preparing a safety file for the EU, registering with the FDA’s VCRP, or adjusting labels for GCC countries, our team makes the process structured and dependable.

We review formulations, validate ingredient usage, and prepare region-ready documentation — always with your launch timelines in mind. Our role doesn’t stop at approval — we stay involved through audits, product updates, and lifecycle maintenance. As a trusted regulatory affairs company for your cosmetics products, with Artixio, you’re backed by regulatory experience that moves with your business.

Cosmetics Regulatory Affairs Process(Global)

Product Assessment
Review formulation, claims, and classification across targeted markets.
Regulatory Strategy
Define submission requirements, market-specific documentation, and labeling rules.
Safety & Claim Review
Ingredient safety check, toxicology summary, substantiation of marketing claims.
Dossier Preparation
Create PIF, CPNP, CNF, or equivalent — formatted per local expectations.
Submission & Notification
File with relevant authorities or notify through portals like CPNP or CNF.
Post-Market Support
Label changes, safety updates, event reporting, renewals, or audits.

Why Artixio for Cosmetics Regulatory Affairs?

Familiar with ingredient restrictions and positive lists across 15+ markets
Local partners for Responsible Person representation and market access
Flexible support — for new launches, reformulations, or post-market updates
Hands-on with ingredient assessment tools like CosIng, PCPC INCI, and country-specific annexes — reducing delays caused by restricted substances.

FAQs

1. Is a safety report mandatory for all cosmetic products?
Yes, most regions require a Cosmetic Product Safety Report (CPSR) or equivalent, especially for skin-contact products. We prepare this based on your formulation data.
Unlikely. Label formats, ingredient disclosures, and claim language vary widely. We help adapt a master label into multiple compliant versions.
We assess if your product qualifies for filing (vs. registration) and whether animal testing can be avoided. Our team keeps up with every NMPA update.
We monitor regulatory changes, track safety alerts, and update your documents or labels when needed — including adverse reaction reports, if required.
Yes. We work through our partners or provide direct services, depending on the region. We also coordinate with your distributor or OEM as needed.

Still Have Questions ?

Get expert answers tailored to your needs.

Specialized Regulatory Affairs
Services Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

Europe

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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