REGULATORY SERVICES FOR COSMETICS INDUSTRIES

  • ISO 22716 and FDA compliance evaluations
  • Global regulatory strategies, FDA 21 CFR, parts 710 & 720
  • Registering cosmetic manufacturing and/or packaging establishments with USFDA
  • Filing Cosmetic Product Ingredient Statements (CPIS)
  • Amending or Discontinuing a Product Formulation
  • Regulatory Consulting, Product Notifications
  • Cosmetics Testing
  • Compilation of Product Information File (PIF)
  • Cosmetic Safety Assessment Report (CPSR)
  • Product Labelling Review & Support
  • EC 1223/2009 (CPR) compliance through the following services
  • A comprehensive review of product portfolios and current certificate expiry dates
  • Gap assessment
  • Remediation and implementation of an EC 1223/2009 compliance plan
  • Compiling application form with declaration to secure LTO from Philippines FDA (AO-2016-0003)
  • Preparation & Review of Risk Management Plan
  • Preparation & Review of Site Master File (SMF)
  • Product Notification (ASEAN Cosmetic Directive)
  • Review of product labelling
  • Review of cosmetic ingredients (IFRA Standards)

Consultation certification for manufacturers

  • Good Manufacturing Practices Certification (ASEAN Guideline)
  • ISO 22716 Certifications
  • ISO 9001:2015 Certifications
  • IFRA Certification
  • IFRA Allergen Certification
  • HACCP Certification

Post Approval support

  • Root cause investigation
  • Corrective and preventive action support
  • Complaint handling
  • Recall management