Preparing a product dossier: Guidelines for establishing and verifying the safety of your products.
Maintenance of safety documentation: Ensuring that all safety verification documentation is available and accessible for regulatory reviews.
Complementary regulatory consulting: Offering free advice on regulatory requirements in the United States for your future products.
Management of exceptional events: Receiving, evaluating, and recording any exceptional event related to your products.
Reporting serious adverse events: Documentation and reporting of serious adverse events to the relevant authorities.
FDA Representation: Acting as your representative in interactions with the FDA.
Support during recalls and inspections: Providing assistance during product recalls, registration suspensions, and regulatory inspections.
Regulatory change updates: Keeping updated on potential regulatory changes that may affect your products.
Note: The following products are not included under United States cosmetic regulations and must be registered as over-the-counter drugs: sunscreen, skin lightening products, fluoride toothpaste, anti-dandruff hair products, deodorants, acne treatment products, hair growth products.
Over 20 years of expertise in regulations
A team of experts for regulation, pharmaceuticals, medical accessories and consumer products
Multilingual staff:
Hebrew, English, Arabic and Russian.
Efficiency, professionalism and reliability
Parallel import process subject to a free import order
Permits and licenses for the export of goods from Israel to any country in the world
Registration of medical preparations and accessories
Supply of licenses and approvals for the various products
Gali Amir provides high quality
effective outsourcing and consultancy,
in Regulatory Services for Cosmetic Products and Quality Assurance.
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