Gali Amir Ltd

Your MoCRA Compliance Partner

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 has transformed the US cosmetics landscape. Gali Amir Ltd is here to help you navigate these new regulations and ensure your products reach the American market smoothly.

Our Services:

  • Responsible Person Support: We act as your US-based regulatory expert, fulfilling all Responsible Person duties and ensuring MoCRA compliance.
  • US Agent Services: We become your trusted US Agent, facilitating communication with authorities and guaranteeing regulatory adherence.
  • Product & Facility Registration: Our team streamlines product and facility registration, guaranteeing safety, timely approvals, and market access.
  • Comprehensive Compliance Solutions: We offer a tailored suite of regulatory affairs and compliance services to meet your MoCRA needs.

Gali Amir Ltd - US Responsible Person Services:

  • Product Safety Substantiation Advice: We guide you in establishing and proving your products’ safety.
  • Safety Documentation Maintenance: We ensure all safety documentation is readily available for review by authorities.
  • Complimentary Regulatory Consultations: We offer free consultations on US regulations for your upcoming products.
  • Adverse Event Management: We receive, evaluate, and record any adverse events related to your products.
  • Serious Adverse Event Reporting: We document and report serious adverse events to the relevant authorities.
  • FDA Representation: We represent you in all interactions with the FDA.
  • Recall & Inspection Support: We assist you during product recalls, registration suspensions, and regulatory inspections.
  • Regulatory Change Updates: We inform you about potential regulatory changes impacting your products.
 

Important Note: Certain products, including sunscreens, skin whiteners, and fluoride toothpaste, are classified as OTC drugs and require separate registration in the US.
Contact Gali Amir Ltd today to ensure MoCRA compliance and gain a seamless entry into the US cosmetics market!

Consulting services

OUR SERVICES

We at Gali Amir Registration and Regulation of cosmetics, medical accessories, and consumer products, including new registration, renewal, parallel importation, preparation, and more.

Consulting, Registration and Regulations.

Our values

WHY US?

YEARS OF EXPERIENCE AND PROVEN TRACK RECORD

Over 20 years of expertise in regulations

A TEAM OF EXPERTS

A team of experts for regulation, pharmaceuticals, medical accessories and consumer products

MULTILINGUAL STAFF

Multilingual staff:
Hebrew, English, Arabic and Russian.

PROFESSIONAL STANDARDS

Efficiency, professionalism and reliability

Industries we serve

Who we serve

Importers

Parallel import process subject to a free import order

Exporters

Permits and licenses for the export of goods from Israel to any country in the world

Manufacturers

Registration of medical preparations and accessories

Suppliers

Supply of licenses and approvals for the various products

CONTACT OUR TEAM

Need Help? | Contact us!

Please allow 48 hours for a response.
Gali Amir provides high quality effective outsourcing and consultancy, in Regulatory Services for Cosmetic Products and Quality Assurance.
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© 2024 ALL RIGHTS RESERVED | ​ Gali Amir Regulatory Services LTD

050-222-9584

Ha-kishor St. 47, Holon

[email protected]