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Expert Cosmetics Regulatory Consulting

Consumer products such as cosmetics, food, dietary supplements, and perfumes are highly regulated worldwide to protect public health and ensure safety. Non-compliance can lead to fines, recalls, border rejections, and reputational damage.

Regulations differ across regions from GCC registrations (e.g. SFDA, Montaji, MoHAP), EU pre-market notifications and UK requirements to US FDA frameworks, each market has unique rules on formulation, labelling and documentation

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Why Partner With Us?

We provide end-to-end regulatory support to ensure efficient, compliant market entry across global markets.

Specialized Expertise

Our team includes qualified regulatory specialists with hands-on experience across consumer products.

Global Reach: Regulatory authorities we work with: Emirates Drug establishment (EDE), Ministry of Health and Prevention (MoHAP), Dubai Municipality (Montaji), Saudi Food and Drug Authority (SFDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Authority (MHRA), United States Food and Drug administration (US FDA), Health Canada (Canadian Health Products and Food Branch) and other emerging markets.

Comprehensive Cosmetics and Perfumes Compliance Services

Endorsements
Analysis

• Guidance on obtaining cruelty-free, organic, and other seals.
• Ensure compliance with standards and guidelines.
• Assist with documentation and application submissions.
• Support maintenance of endorsement status.
• Advise on branding and marketing use.
• Monitor updates and assist with renewals.

Cosmetics Product Notification/Registration

• Classify products according to applicable regulations.
• Compile Product Information Files (PIF) or dossiers.
• Complete product notification or registration as required.
• Provide RP/LR services or appoint authorized local representatives.

Cosmetics Product Safety Assessment

• Prepare toxicology reports for cosmetic ingredients.
• Create and review CPSRs with a qualified safety assessor.
• Calculate margin of safety for each ingredient.
• Recommend suitable labs and clinical tests for finished products.
• Guide on required safety tests based on ingredient profiles and available data.

MI , RI & TI

Market Intelligence (MI)
• Market trends, competitor analysis, and growth insights.
• Region-specific strategies and periodic reports.
Technical Intelligence (TI)
• Emerging technologies, patents, and R&D tracking.
• Risk assessment, opportunities, and technical updates.
Regulatory Intelligence (RI)
• Regulatory overviews, fees, timelines, and documentation.
• Region-specific compliance support and periodic updates.

Label review and
formula review

Label review
• Label Review and Regulatory Compliance.
• Verify Consumer information and Language Assistance.
• Labeling, Packaging and Compliance Support.
Formula Review
• Ingredient Combinations and Safety.
• Product Classification and Regional Compliance.
• Pre-formulation Assessment and Reformulation Recommendations.
• Ingredient Compliance and Import Requirements.

Claim Support

• Claim validation.
• Analyze scientific data.
• Marketing, regulatory approval.
• Regulatory Compliance.
• Industry Trends.
• Risk Mitigation.
• Claim Substantiation.

Comprehensive Food and Dietary Supplements Compliance Services :

Go to
Markets

• Overview of regulatory processes, timelines, and fees.
• Local/legal representation and MAH support.
• Compliance assistance, on-site support and training.
• Regulatory updates on HA changes.
• Develop regulatory roadmap and strategy.
• Support OTC-to-dietary supplement transition.

Label
Review

• Labeling expertise for food supplements and nutraceuticals.
• Ensure compliance and manage label updates.
• Language assistance.
• Update Supplement Facts and nutritional panels.
• Conduct region-specific gap analyses.

Formula Review & Product Classification

• Review formulas for ingredient compliance.
• Classify products per region-specific regulations.
• Conduct pre-formulation assessments.
• Recommend reformulation strategies.
• Identify prohibited, novel, and NDI ingredients.

Submission, Registration/Notification

• Conduct gap analysis and compile Dossiers/Technical Fites/PIFs.
• Ensure label compliance and assessments.
• Develop regulatory strategies and pathways.
• Generate product classification reports.
• Manage NDI notifications (USFDA).
• Facilitate Novel Food registrations.

Technical Documents/ Lifecycle Methods

• Compile registration documents and ensure HA compliance.
• Review dossiers for safety reports.
• Recommend mandatory supporting documents.
• Provide product compliance reports.
• Manage NPD activities: approvals, registrations, renewals, SKUs, promotions.

Our Regulatory Process

Product Classification

Determine regulatory category, applicable frameworks, and target market requirements for your specific product.

Gap Analysis

Review formulation, ingredients, labelling, claims and existing documentation against target market regulatory standards.

Safety Assessment

Commission safety reports (Cosmetic Product Safety Report for cosmetics), prepare safety dossiers, coordinate required testing

Dossier Preparation

Compile complete Product Information File (PIF), regulatory dossier, or registration package per market requirements.

Labelling & Claims

Review and approve artwork, ingredient declarations, allergen statements, claims, warnings, and mandatory statements.

Authority Submission

Submit notifications or registration applications to relevant authorities (Dubai Municipality- Montaji, SFDA, CPNP, etc.) and manage e-portals.

Query Management

Respond to authority questions, provide additional data if requested, manage any deficiency notices professionally.

Approval & Launch

Obtain certificates, approvals, or confirmation of notification. Coordinate import clearance if required. Product launch support.

Frequently Asked Questions

QRServes provides end-to-end regulatory support for consumer products including cosmetics, food, dietary supplements, and perfumes across global markets. Services cover product classification, formulation compliance, labelling reviews, dossier preparation, and full registration management with authorities such as the UAE’s MoHAP and Dubai Municipality (Montaji), Saudi Arabia’s SFDA, the EU, UK MHRA, US FDA, and Health Canada.

To register a Cosmetic product in UAE with Montaji, you need to have UAE Company’s Trade License, Full ingredient list, Product Formula, Stability data, Certificate of Analysis (COA), Product Safety Assessment, Free Sales Certificate , Labelling and Art Work in Arabic and English, Good Manufacturing Plan (GMP) of the plant, Manufacturing License of the Plant, Proof of claims. 

Each market has its own regulatory framework governing formulations, labelling standards, permitted ingredients, and documentation requirements. For example, GCC markets such as the UAE and Saudi Arabia require local product registration portals like Montaji and SFDA, the EU requires pre-market notification under the Cosmetics Regulation, and the US FDA operates a different notification and labelling framework. Non-compliance in any market can lead to product recalls, border rejections, fines, and reputational damage.

To register a Food product in UAE with Dubai Municipality, you need to have UAE Company’s Trade License, Full ingredient list, Labelling and Art Work in Arabic and English. Labelling should be compliant with IRS guidelines.

To register a Dietary supplement product in UAE with Dubai Municipality, you need to have UAE Company’s Trade License, Full ingredient list, Certificate of Analysis, Good Manufacturing Plan (GMP) of the plant, Free Sales Certificate, Labelling Arabic and English, Clear Image of the Product, Clear Art Work, Other supporting Endorsements.

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