Lets Get Started with QualConform
Looking for a Solution Like This?
Contact Us and Get a Quote Within 24 Hours!
– Regulatory status determination (cosmetic vs. drug)
– Global regulatory landscape assessment
– Formulation strategy aligned with regulatory requirements
Toxicological risk assessments for ingredients
– Safety data review and gap analysis
– International ingredient regulations compliance (e.g., EU REACH, California Prop 65)
– Safety assessments for finished products
– In vitro and in vivo testing strategy development
– Quantitative risk assessment (QRA) for fragrance allergens
– Cosmetic claim categorization (structure/function vs. drug claims)
– Claim substantiation study design and protocol development
– Scientific literature review and evaluation
– FDA Draft Guidance on Cosmetic Good Manufacturing Practices compliance
– ISO 22716 (Cosmetics GMP) implementation and certification support
– Quality manual and Standard Operating Procedure (SOP) development
– Raw material and finished product testing strategies
– Microbial contamination control programs
– Stability testing and shelf-life determination
– Supplier qualification and audit programs
– Raw material specifications and Certificate of Analysis (COA) review
– Supply chain risk assessment and mitigation strategies
– cGMP compliance for cosmetics (FDA draft guidance)
– Color additive compliance assessment
– Modernization of Cosmetics Regulation Act (MoCRA) compliance preparation
– EU Cosmetic Product Regulation compliance
– China NMPA (National Medical Products Administration) registration
– ASEAN Cosmetic Directive compliance
– Canada Natural Health Products Regulations for cosmetics
– Cosmetic labeling requirements (21 CFR Part 701) compliance
– Ingredient declarations and nomenclature (INCI names) support
– SPF and broad-spectrum protection labeling for sunscreens
– Professional use and salon product labeling
– Voluntary Cosmetic Registration Program (VCRP) filings
– Cosmetic Product Ingredient Statements (CPIS) preparation and submission
– EU Cosmetic Product Notification Portal (CPNP) submissions
– China NMPA notification and registration dossiers
– Website content review for regulatory compliance
– Social media and digital marketing guidance
– Print and broadcast advertising material assessment
– Regulatory compliance final check
– Market-specific regulatory requirements confirmation
– Launch timeline alignment with regulatory milestones
– Adverse event reporting system development
– Serious adverse event investigation and reporting to FDA
– Trend analysis and signal detection
– FDA inspection readiness and support
– FDA Warning Letter and regulatory correspondence response
– Annual renewals and updates (e.g., VCRP, international registrations)
– Regulatory intelligence gathering and impact analysis
– Proactive compliance strategy development
– Emerging regulatory trend identification
– Formulation changes impact assessment
– Label update management
– Claim substantiation maintenance
Read more about Posr-market activities