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PHI Corporation

COSMETICS

& COSMECEUTICALS

REGULATORY AFFAIRS SERVICES FOR

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

Lab Work

✔ 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