Complete Solution for FDA Regulation.

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.

FDA Consulting for Cosmetics, Medical Devices and Food

Solutions

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

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

FDA 510k, FDA Consulting, FDA Cosmetic Registration

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

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

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

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

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.

Logistics Operation in the USA

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

CFG FDA, FDA Foreign Government Certificate

We offer a specialized service in obtaining and authenticating FDA "Foreign Government Certificates" for companies exporting to the USA. Additionally, we guarantee "Consular Authentication", ensuring official recognition of certificates by relevant consulates and embassies.