Precision and focus on solutions
About Us
Our team has extensive experience working with the FDA, ranging from medical devices, cosmetics to dietary supplements. We excel at FDA compliance and regulatory affairs, bringing our expertise to your business to help you meet FDA requirements. Our goal is to ensure that our clients are fully informed and properly equipped to deal with all FDA-related challenges.
We provide FDA consulting services for medical devices, cosmetics and foods. We apply our expertise by driving innovations in the regulatory field and expanding possibilities with each new project. Our goal is to guide our customers, ensuring that their products meet all the necessary requirements to be sold in the USA.
Our focus areas
Activity Sectors
Maximize your FDA compliance for medical devices! Count on our specialized consultancy to navigate regulations and ensure that your product meets all required standards. Make the process simpler, safer and more effective with us.
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Boost compliance and innovation in your cosmetics! Count on our specialized consultancy to comply with sector regulations and ensure that your product stands out in the market. Turn your ideas into success with us.
Ensure the excellence and safety of your foods and supplements! With our expert advice, confidently navigate FDA regulations, ensuring your products meet all required standards. Leverage your business in the market with our expertise.
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We offer integrated logistics solutions for operations in the American market. We serve as an FDA Initial Importer, ensuring compliance with regulations and serving as a point of contact with the FDA. Additionally, we provide customs services, facilitating the import process. We have certified storage facilities, ensuring that products are kept in ideal conditions. If necessary, we offer reprocessing of products, adjusting them for the local market. Our focus is to optimize your entry and operation in the American market, ensuring efficiency and compliance.
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We Plan, We Implement, We Deliver.
Solutions
We offer a full range of services, from initial planning, gap analysis, to post-approval follow-up and representation management. Our goal is to ensure that your company and products are fully qualified to be sold in the USA. At every step, we commit to the highest standard of professionalism.
What We Offer.
Based on the research, a detailed plan is developed to address all regulatory requirements. This plan can include deadlines, required resources, and specific steps.
Regulatory Planning
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Comparison of the current state of the product or system with FDA requirements to identify "gaps" or deficiencies that need to be addressed.
Gap Analysis
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Once the product is in compliance, the next step is to prepare and submit all necessary documentation to the FDA. This can include test reports, product details, labeling and more.
Product Registration
Preparation and Submission
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FDA will review all documentation and may request additional information or clarifications. During this phase, we provide continuous monitoring, acting as a local agent between the FDA and the manufacturer, ensuring that all interactions are clear, effective and meet the expectations of both parties.
Product Registration Regulatory Monitoring
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Understanding the importance of Good Manufacturing Practices (GMP) established by the FDA, we offer specialized services in the implementation and adaptation of Quality Management Systems. Our goal is to ensure that your company not only meets, but exceeds required quality standards by ensuring that your products are consistently produced and controlled to the highest standards.
Implementation
Quality Management System
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In addition to managing interactions or communications with the FDA in an effective and professional manner, we serve as the FDA's local agent for regulatory representation in the United States. This agent serves as the on-site focal point, facilitating communications, ensuring compliance with local regulations, and promptly responding to FDA requests.
FDA Local Agent
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Recognizing the challenges of operating logistically in a market as vast and diverse as the United States, we offer strategic logistics services within the American territory. From import management, adequate storage to the efficient distribution of your products, we guarantee an integrated logistics solution that meets your needs.
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We offer a comprehensive range of services in FDA Regulatory Affairs, ranging from specialized training in various areas of the FDA, ensuring UDI compliance, to consulting on Trademark issues, among other topics essential for an effective and regulatory-compliant operation.
Other Regulatory Matters
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Schedule a call with us
Call or fill out the form to request more information.
Tel. +55 (11) 3042 7557
Tel. +1 (786) 600-1081
Fax +1 (786) 610-1183
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