ENABLE YOUR EXPORTS WITH GUARANTEED REGULATORY COMPLIANCE
FDA Enterprise is a specialized service for large international companies that need credentialing and registration with the Food and Drug Administration (FDA) to legally export to the United States. With an optimized process and complete support, we guarantee that your factory and products are in total compliance with American regulatory requirements, opening doors to the world's largest consumer market.
WHY FDA REGISTRATION IS ESSENTIAL FOR LARGE EXPORTERS
MANDATORY LEGAL COMPLIANCE
- Large manufacturers must obtain FDA registration to commercialize in the US
- Products without registration can be retained at US customs
- Severe fines can be applied for commercialization without US registration
- Potential blocking of future exports to the US in case of non-compliance
- Legal responsibility on manufacturers and distributors in the American market
CREDIBILITY AND COMPETITIVE ADVANTAGE
- Approval seal from one of the most respected American regulatory agencies in the world
- Greater trust from American buyers and distributors
- Access to American retail networks that require FDA compliance
- Competitive advantage over non-registered competitors in the American market
- Increase in perception of quality and safety of the product in the American market
BRAND AND BUSINESS PROTECTION
- Legal security to operate in the American market
- Mitigation of American regulatory risks and recalls
- Preservation of brand reputation in the American market
- Protection against legal challenges from American competitors
- Prevention of financial losses from American cargo retention
OUR FDA REGISTRATION PROCESS IN TWO STAGES
STAGE 1: APPLICATION AND REGISTRATION PROTOCOL
In this first phase, we prepare and submit all necessary documentation to initiate your American FDA registration process:
- Preliminary analysis of eligibility and FDA registration category
- Complete and accurate completion of FDA application forms
- Compilation of American technical and regulatory documentation
- Official protocol of registration with the American regulatory agency
- Verification and validation of information submitted to FDA
- Support for clarification of doubts during the FDA process
- Active monitoring of FDA application status
STAGE 2: AGENCY AND REPRESENTATION BEFORE FDA
Our service continues with legal representation of your company before the American regulatory body:
- Official intermediation between your company and American FDA
- Direct communication with American regulatory authorities
- Acting as your U.S. Agent (legal representative in the US)
- Receipt and forwarding of official American communications
- Monitoring of applicable American regulatory updates
- Support for resolution of pending issues and FDA questions
- Guarantee of continuous compliance with American regulations
ADDITIONAL SERVICE: LABEL AND INGREDIENT ANALYSIS
Para produtos com ingredientes ativos ou composições específicas, oferecemos um serviço especializado de análise de conformidade:
- Verificação completa da composição do produto segundo regulações americanas
- Identificação de ingredientes proibidos ou restritos nos EUA
- Análise de dosagens permitidas conforme regulamentação FDA
- Avaliação de enquadramento em categorias especiais (OTC, medicamentos, etc.)
- Verificação de conformidade de rotulagem para o mercado americano
- Recomendações para adequação quando necessário
- Documentação técnica para suporte ao registro
DIFFERENTIALS OF OUR FDA ENTERPRISE SERVICE
PROVEN EXPERIENCE
- Success track record with hundreds of approved FDA registrations
- Deep knowledge of American FDA regulations and their updates
- Established relationship with American regulatory authorities
- Understanding of particularities of different product categories in the American market
- Team specialized in American compliance
OPTIMIZED AND EFFICIENT PROCESS
- Refined methodology that eliminates rework and delays in the FDA process
- Double verification system that minimizes FDA submission errors
- Advance preparation for potential American FDA questions
- Templates and guides that streamline information collection for FDA
- Proactive monitoring that reduces FDA approval time
COMPLETE INTERNATIONAL SUPPORT
- Multilingual team that eliminates communication barriers with FDA
- Specialized technical translation of documents necessary for FDA
- Clear explanations about American FDA requirements and procedures
- Continuous advisory during the entire FDA process
- Quick resolution of doubts and questions related to FDA
APPROVAL GUARANTEE
- Commitment to concrete FDA results, not just processes
- Prior viability analysis to avoid frustrated attempts at FDA
- Proactive approach to anticipate and resolve potential FDA objections
- Follow-up until obtaining definitive FDA registration
- Support for adaptations if necessary for FDA approval
WHICH COMPANIES IS FDA ENTERPRISE INDICATED FOR?
FOOD AND BEVERAGE MANUFACTURERS
- Processed products for human consumption in the American market
- Food and nutritional supplements for Americans
- Special and functional beverages for the American market
- Foods with specific health claims for Americans
- Food additives for the American market
COSMETIC AND PERSONAL CARE INDUSTRY
- Cosmetics and hygiene products for Americans
- Skin and hair care products for the American market
- Makeup and perfumery for American consumers
- Baby products and special care for the American market
- Cosmetics with specific actives for Americans
MEDICAL DEVICE MANUFACTURERS
- Medical equipment and supplies for the American market
- Diagnostic devices for Americans
- Health technologies for the American market
- Dental products for American consumers
- Wellness and health equipment for the American market
OTC MEDICINE PRODUCERS
- Over-the-counter medicines for Americans
- Symptom relief products for the American market
- Daily health solutions for American consumers
- Non-prescription therapeutic products for Americans
- Medical supplements for the American market
INVESTMENT WITH GUARANTEED RETURN
FDA Enterprise is a strategic investment with measurable return for your operation in the American market:
- Elimination of American regulatory risks that could cost thousands of dollars in retained products
- Immediate access to the richest American consumer market in the world
- Increased credibility for negotiations with American distributors and retailers
- Protection of brand and investments already made in products and marketing for Americans
- Competitive differentiation in relation to non-registered competitors in the American market
GUARANTEE YOUR FDA COMPLIANCE TODAY
The American market is within your reach, but FDA regulation is non-negotiable for large exporters. Don't allow American regulatory barriers to limit your company's potential in the American market.