Navigating the complex landscape of FDA compliance can be a challenging journey for businesses in the pharmaceutical and food industries. At Ketki Food Safety, we offer a comprehensive range of services designed to ease the process and ensure that your products meet the stringent requirements set by the FDA.
What are FCE and SID Filings?
- Foreign Facility Certification (FCE) – If your business operates outside of the United States and intends to export FDA-regulated products to the U.S., FCE filing is a crucial step. This certification demonstrates that your facility complies with FDA regulations and is eligible to export to the U.S.
- Substance Inventory Database (SID) – For manufacturers of food and food-related products, SID filing is essential. It involves listing the substances used in your products to ensure their safety for consumers. Accurate SID information is vital for compliance with FDA regulations.
What We Do
- FCE Certification – We assist foreign facilities in preparing and submitting the necessary documentation for FCE certification, ensuring compliance with FDA requirements.
- SID Filing – For food product manufacturers, we provide support for accurate SID filing, helping you list and manage substances used in your products.
- Compliance Monitoring – We offer ongoing monitoring and support to ensure your business remains in compliance with FDA regulations, helping you avoid potential issues and delays.
Benefits
- Market Access – FCE and SID compliance pave the way for market entry into the United States, opening up new opportunities for your business.
- Consumer Safety – Compliance demonstrates your commitment to product safety, building trust among consumers and partners.
- Regulatory Assurance – You can operate with confidence, knowing that your products meet FDA standards, reducing the risk of costly penalties.
Why Choose Our FCE and SID Filing Services?
Expertise – Our team comprises of FDA compliance experts who understand the intricacies of FCE and SID filings and keep up with regulatory changes.
Simplified Process – We streamline the often complex filing process, ensuring accuracy and efficiency.
Global Reach – Our services extend worldwide, making it easy for international businesses to access the U.S. market.
Comprehensive Support – We guide you from the initial application through to approval and provide ongoing compliance assistance.
Get Started Today
We are dedicated to simplifying the process of FCE and SID filing, ensuring your products meet FDA compliance standards. Whether you’re an international manufacturer or a local food producer, our services are designed to help you access the U.S. market while prioritizing the safety and quality of your products. Contact us today to take the first step toward FDA compliance and market expansion.