Regulatory Support for Cosmetic Product Registration in USA
Cosmetics Regulatory Services in U.S Market with MoCRA Compliance
Country Specific Services
The U.S.cosmetics market is among the world’s largest and most closely monitored.With the introduction Regulatory
of the Modernization of Cosmetics Regulation Act(MoCRA), the U.S.Food and Drug Administration(FDA) has elevated oversight standards to ensure transparency, safety, and accountability across every stage
Pharmacovigilance
of cosmetic product manufacture and distribution. At DDReg, we help cosmetic brands, manufacturers, and importers navigate this transformation with
Labeling
strategic precision. Our cosmetic regulatory specialists translate FDA expectations into executable compliance frameworks, supporting cosmetic product registration in USA, market access, operational
IPR Support
alignment, and ongoing readiness in one of the world’s most competitive markets.
Clinical Trial Regulatory
U.S.Cosmetics Regulatory Requirements under MoCRA
Medical Devices regulatory services
Key Registration Routes under CDSCO Requirement
Key Details
Facility
Every establishment (domestic or foreign) that manufactures or processes
Registration
cosmetics for U.S. distribution must register. Renewal is biennial.
Product
Each product must be submitted by the “responsible person” with details
Listing
including ingredients, label name, manufacturing site FEI, etc.
Submission Portal & Format
Use FDA’s Cosmetic Direct portal and SPL format for electronic submission of cosmetics facility registrations and product listings.
Deadline &
While MoCRA became effective December 29, 2022, the FDA’s enforceable
Enforcement
deadline for many requirements was extended to July 1, 2024. Small businesses (under certain sales thresholds) and certain product types may
Exemptions
qualify for exemptions, but key product categories remain subject to full requirements.
Our End - to - End US Cosmetics Regulatory Compliance Services + Regulatory Pathway & Compliance Strategy + Cosmetics Facility Registration & Product Listing Services + Ingredient Review & Labeling Compliance + Safety Substantiation & Toxicological Review + Adverse Event Reporting & Post-Market Surveillancent + U.S. Agent & Responsible Person Support + Regulatory Intelligence & Continuous Compliance Why Choose DDReg as Cosmetics Regulatory Services in USA ? DDReg stands at the forefront of < a href = "/solutions/regulatory-intelligence" > regulatory intelligence and execution in cosmetics compliance.We combine technical mastery with practical understanding, empowering brands to maintain speed, accuracy, and sustainability in their U.S.operations.Our MoCRA experts provide not only procedural support but also strategic insight that strengthens your compliance posture and safeguards your brand reputation. With extensive experience supporting non-U.S. cosmetic manufacturers, DDReg ensures seamless coordination between your global teams and the FDA’s regulatory systems, helping you achieve fasttrack readiness without operational disruption. Connect with DDReg’s MoCRA consultants today for a comprehensive compliance assessment and tailored cosmetics registration strategy.
Connect with DDReg’s MoCRA consultants today for a comprehensive compliance assessment and tailored cosmetics registration strategy.
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