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PHI Corporation
COSMETICS
& COSMECEUTICALS
REGULATORY AFFAIRS SERVICES FOR
OUR
SERVICES.
END-TO-END COSMETIC REGULATORY SUPPORT
We help companies comply with their regulatory requirements by providing an end-to-end cosmetic regulatory solutions from large companies to small and medium businesses along with micro businesses.
✔ Formulation and Ingredient Assessment
✔ Starting Materials Compatibility Review
✔ Claims Review and Recommendation
✔ Facility Compliance and Audit
✔ Quality Management System Support
✔ Documentation
✔ Labelling Compliance
✔ Regulatory Submission & Representation
✔ Marketing Authorization Post-issuance Compliances
PRODUCT DEVELOPMENT
FORMULATION AND INGREDIENTS ASSESSMENT
✔ Chemical Categorization
✔ Starting Material Sourcing and Coordination
✔ Acceptance Limit Analysis
✔ Claims Review and Preparation
✔ Formulation and Re-formulation Consulting
✔ Packaging and Labeling Requirements Review
✔ Product Information File/ Dossier Creation
✔ Marketing Materials Consultation
✔ Safety Assessment
COSMETIC CLAIMS & COMPLIANCE
✔ Claims Substantiation
✔ Recommendation on Restrictions
✔ Recommendations on Label Compliance
✔ Review and Preparation on Claims
✔ Marketing Strategies on Claims
✔ Marketing Materials Compliance
COSMETIC LABELS REVIEW
✔ Claims Substantiation
✔ Recommendation on Restrictions
✔ Recommendations on Label Compliance
✔ Review and Preparation on Claims
✔ Marketing Strategies on Claims
✔ Marketing Materials Compliance
SAFETY ASSESSMENT
✔ Chemical Categorization
✔ Compatibility Review
✔ General Toxicological Reporting
✔ Review and Preparation of Cosmetic Data
✔ Label Strategies
✔ Cosmetic Safety Data Sheet Authoring
PRODUCT INFORMATION FILE AUTHORING
✔ Content Authoring
✔ PIF Review
✔ PIF Updating
✔ Proof of Claim Substantiation
✔ Country-specific Requirements Conversion
✔ Amendments and Variations
REGULATORY INTELLIGENCE
✔ Business to Regulatory Alignment
✔ Regulatory Requirements Update
✔ Product Development Strategies Support
✔ Analyses on Draft Regulatory Authority Documents
✔ History and Trends Analysis
✔ Risk Analysis and Risk Minimization
REGULATORY STRATEGIES
✔ Product Development to Commercialization Strategies
✔ Risk Assessment
✔ Artwork Label Design
✔ Regulatory Submission Strategies
✔ Product Launch Strategy
✔ Strategies on Regulatory Changes
IN-COUNTRY
REGULATORY REPRESENTATION.
We help companies to launch their products in a target country or region. We collaborate with our clients and immerse ourselves to their business to ensure that our strategies are aligned with their business goals.
✔ Health Authority Technical Liaising
✔ Coordination and Updates
✔ Compliances
✔ Review, Preparation and Submission
✔ Country-specific Labelling Conversion
✔ Regulatory Updates
✔ Amendments and Variations
✔ Timely Renewals
✔ Answers to Health Authority Queries
✔ Document Control
✔ Archiving
✔ Customs Assistance