COSMETICS CONSULTING

CosmeticsConsulting Services

We help with your challenges involving quasi-drugs, cosmetics, quasi-drug ingredients and cosmetic ingredients.

COSMETICS ISSUES

Facing any of these challenges?

Select the area closest to your challenge to see the related support.

We want to file a quasi-drug application We want a GCP audit before human studies such as SPF testing

SERVICE AREA

Cosmetics Consulting Service Areas

We address challenges at every stage, from development through manufacturing and marketing to distribution.

Cosmetics & Quasi-drugs Development, Manufacturing & Marketing, Distribution

Basic ResearchBasic research
NonclinicalNonclinical
Clinical TrialsClinical trial
ApprovalApproval
Manufacturing & MarketingMarketing authorization
DistributionDistribution

SHARED REGULATORY LANDSCAPE

Areas Shared with Pharmaceuticals & Regenerative Medicine Products

See the common process from development to distribution, overlaid with the standards that apply to each product and our cross-functional support.

MEDICINE Pharmaceuticals GMP / GQP / GVP / GDP / GCP / GLP REGENERATIVE MEDICINE Regenerative Medicine Products GCTP / CPC / manufacturing & quality control

COSMETICS / QUASI-DRUGS Cosmetics & Quasi-drugs ISO 22716 / EFfCI / cGMP

Cross-functional Support Development & Regulatory Support Operational Support Audit & Inspection Support Training & Talent Development

Building on the quality, manufacturing and development principles shared with pharmaceuticals and regenerative medicine products, we address challenges specific to cosmetics and quasi-drugs.

01Development Stage

Quasi-drugsDevelopment & applications GCPClinical trials

Available Services

Quasi-drug development and application support Scheduling the preparation of application documents Related technical information and patent searches Validation planning support Advice on inquiries from regulatory authorities GCP audits before human studies such as SPF testing

View Development & Regulatory Support

02Manufacturing & Marketing Stage

ISO 22716Cosmetics GMP EFfCICosmetic ingredient GMP cGMPUS regulatory compliance

Available Services

ISO 22716 implementation and operational improvement EFfCI certification support Support for transitioning to cGMP operations Gap analysis and improvement prioritization Preparing and revising documents and SOPs Training and validation support

View Cosmetics GMP Support

03Distribution Stage

FDAInspection support cGMPUS exports AUDITSupplier audits

Available Services

cGMP compliance for exports to the US Training and gap analysis before FDA inspections Q&A training and English translation of documents Accompanying plant tours and back-room support during inspections Drafting and reviewing Form 483 responses Supplier audits and auditor skill improvement

View FDA Inspection Support

CONSULTING FLOW

Our Cosmetics Consulting Process

We assess your current situation, organize the issues, and propose solutions that fit your goals.

STEP 01Identify the issues
We interview you about your current operations and the goals you are aiming for.
STEP 02Gap analysis
We analyze the gaps between regulatory and guideline requirements and your current situation.
STEP 03Proposed solutions
We organize the issues identified and propose priorities and how to implement them.

Gap AnalysisGap analysis

We analyze the gap between the requirements of laws and guidelines and your current situation, and organize the issues and risks. Based on the results, we propose improvement priorities and solutions that fit your goals.

View Gap Analysis Details

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