Our company works in affiliation with the U.S. based company Register-FDA that offers comprehensive FDA Registration Service tailor-made for companies in U.S. as well as Non-U.S. companies. Our company is located in Ahmedabad, India and works hand-in-hand with Register-FDA to assist and support the Indian companies get registered with US FDA, so that they can export their products in U.S. in a smooth manner. We offer a variety of US FDA Registration Service including USFDA Certification Qatar, US FDA Certificate UAE, US FDA Certificate Bahrain, USFDA Certification Middle East and US FDA Registration Service for Tobacco products.
If the company exporting products to U.S. do not get registered under FDA, then the government of the United States may not permit the shipment of the company, leading to monetary loss of all storage, transportation apart from their products getting disapproved from being marketed in the U.S. market. The federal government is likely to take criminal actions in federal court to prosecute, and inhibit the company from ever again exporting their products to the United States.
Samrat Associates, we are dedicated to providing expert consultancy services for navigating the complexities of US FDA regulations in India. Our team, led by Dr. Abhimanyu Samrat, brings over 22 years of experience in management consulting and regulatory compliance across various industries. Our consultants are well-versed in US FDA regulations and possess extensive experience in various sectors including food processing, pharmaceuticals, and medical devices. We assist manufacturers, exporters, and suppliers in registering their products and facilities with the U.S. Food and Drug Administration (FDA), ensuring compliance with the latest regulations. FDA inspections are crucial for companies looking to enter the US market. We conduct mock audits, identify compliance gaps, and provide guidance to ensure a smooth FDA inspection process.
The US FDA enforces strict regulations on food and dietary supplements. We guide businesses through FSMA (Food Safety Modernization Act) compliance and other FDA regulations. Our services include US FDA establishment registration, DMF/ANDA/NDA filings, 510(k) medical device submissions, FSMA compliance, and cosmetic product registration. With a proven track record, cost-effective solutions, and a team of experienced professionals, we help companies navigate complex FDA regulations seamlessly. Contact Samrat Associates today for end-to-end FDA compliance consulting and expand your business globally!
Our Services
Registering with the U.S. Food and Drug Administration (FDA) for food and beverage products involves several steps to ensure compliance with regulations.
Register your manufacturing facility with the FDA through the Food Facility Registration system
Drug manufacturers need to comply with FDA regulations, including Good Manufacturing Practices (GMP), and may undergo inspections by the FDA to ensure compliance.
Manufacturers should be aware of and comply with specific regulations and guidelines set forth by the FDA for cosmetics, ensuring they are not adulterated or misbranded.
Emphasizing expertise, compliance, customization, and ongoing support throughout the regulatory process for medical devices.
Registering tobacco products with the FDA involves different steps compared to other FDA-regulated items due to the unique regulations governing tobacco.
The US FDA Certificate stands as a beacon of assurance for our customers, signifying that our products have undergone rigorous evaluation and have met the stringent criteria set by the FDA for safety, efficacy, and quality. This endorsement reflects our dedication to providing consumers in the UAE with products that align with the highest international benchmarks.
we recognize the global significance of the US FDA, making our certification a symbol of trust that extends beyond borders. Our decision to pursue and obtain this certification demonstrates our commitment to global best practices, ensuring that our products are not only compliant with US standards but also resonate with the discerning consumers in the UAE / Dubai, Qatar, Saudi Arabia.
