Services

• Compliance Review:
○ Ingredient acceptability and limits in the US and many foreign countries
○ Harmonized labeling, both domestic and international
○ Product claims review
○ Website and marketing materials claims review

• Registrations/Notifications:
○ California Safe Cosmetics Act
○ Canada Cosmetic Notification
○ WercSmart Submission
○ US FDA Voluntary Cosmetic Registration Program (VCRP)

• US FDA OTC Topical Drugs:
○ Facility and formula registrations
○ Annual renewals
○ Drug Facts labeling review
○ Monograph compliance review
○ Product claims review

• SDS / CARB
○ Safety Data Sheet Authoring for Finished Good Cosmetics, Topical OTC Drugs, and raw materials in compliance with OSHA HazCom 2012 (GHS)
○ California Air Resources Board (CARB) Survey Submission

• Registration/Representation for foreign companies wishing to sell US OTC drugs
• Product Information Files (PIF Dossiers) Guidance for EU

• E-Blasts:
○ Pending cosmetic federal and state legislation
○ Prop 65 updates
○ International cosmetic regulatory issues
○ EU Cosmetic Regulation updates
○ Enforcement activities (US FDA warning letters, NAD actions)