Cosmetics

Importers and distributors selling cosmetics in Israel, and Israeli manufacturers – including exporters, can trust Dor Pharmaceutical Services to smoothly navigate the regulatory landscape, which is stricter than other countries, such as the US. Dor’s comprehensive solutions help companies obtain product-marketing approval for the complete range of cosmetics, including baby products, personal hygiene, make-up and fragrances.

New: Dor is set up and ready to support the new Israeli Ministry of Health (MOH) cosmetics directive and guidelines (adaptation to the European Regulation No 1223/2009 with few local modifications). Dor offers a fully comprehensive service that will allow you to prepare yourself quickly and efficiently to the new requirements.

Customers benefit from Dor’s expertise and experience that support the cosmetics product lifecycle, from manufacturing and packaging to labeling and distribution, including:

Supporting the new cosmetics directive adapted to the European Regulation

Services of a Responsible Person (RP)

Writing, assembling & maintenance of the Cosmetic Product Information File (PIF) your products as required under the new directive

Writing of Safety Assessments by a European qualified Safety Assessor (SA)

Notification to the Ministry of Health on commencement of marketing

Assistance in ratifying claims

Preparation of labeling and packaging materials for cosmetics under Good Manufacturing Practice (GMP) standards including translation and graphics.

Outsources Central management and call center for public referrals

Receipt and reporting cosmetic products Adverse Events

Laboratory testing and clinical trials according to registration requirements to meet requested claims

Regulatory Affairs

Regulatory affairs department outsourcing New product submissions and follow-up till approval Post-approval support (renewals, variations, import issue resolution, extensions for additional claims, etc.) Business development and due diligence Regulatory affairs consulting Regulatory second opinions

Cosmetics Labeling & Localization

In Israel’s stringent regulatory environment, Dor’s cosmetics labeling, packaging and localization solution offers outstanding advantages for quality, speed and compliance. Dor adapts and translates all labeling elements to local regulatory requirements, formats and languages, designs graphic artwork and prints all cosmetics packaging elements so they are ready for assembly