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
