Certifications

HOMECertifications
USFDA REGISTRATION

UNITED STATES FOOD AND DRUG ADMINISTRATION AGENCY REGISTRATION

The United States Food and Drug Administration (FDA) is a Federal Agency of the Department of Health and Human Services. The FDA is responsible for Protecting and Promoting Public Health through the Control and Supervision of Food Safety, Tobacco Products, Dietary Supplements, Prescription & Over-The-Counter Pharmaceutical Drugs (Medications), Vaccines, Biopharmaceuticals, Blood Transfusions, Medical Devices, Electromagnetic Radiation Emitting Devices (ERED), Cosmetics, Animal Foods & Feed and Veterinary Products. In order to be able to sell a product in the United States, you need to register with the US Food and Drug Administration for US FDA Registration. This is a process that involves submitting an application and paying a fee. Every company that makes a product for sale in the USA is required by law to register with the FDA. This assures that all items sold in the United States meet a set of quality criteria. FDA Registration benefits both consumers and companies. Those registered with the FDA are eligible for a variety of marketing advantages that might help them boost their overall business and exports to USA as well as other countries. The FDA regulates many products that are intended for human consumption, including food and medical devices. In addition to registering your product with them, you will also need to comply with all other applicable laws and regulations. This includes following Good Manufacturing Practices, which are guidelines for how to manufacture products safely. When you register your product with the FDA, you’re confirming that it’s been tested and found to be safe for public use. You also have to include information about how to use the product, what results you can expect from using it, and any possible side effects or risks.

Varied Industrial Applications

Varied Industrial Applications of USFDA Registration

Animal &
Veterinary Industry

Cosmetics
Industry

Drugs & Medical
Devices Industry

Food & Beverage
Industry

Radiation-Emitting
Products Industry

Tobacco
Products Industry

Vaccines, Blood
& Biologics Industry

benefits

Benefits of USFDA Registration

FDA Approval extends the scope of your company's expertise thereby constantly helping in updating, upgrading, and improving it constantly.

Medical facilities and hospitals will only consider a food or medical product if it has received FDA approval thereby help grow your network.

When the FDA approves your product, you'll also receive a Certificate of Foreign Government Approval (CFG) and gain access to global markets.

In terms of demand, products that have received FDA approval quickly rise to the top and the demand for your product will increase.

Ensures product safety and good manufacturing practices (GMPs) are implemented & quality requirements are consistently met.

Helps to gain access to international market & provides increased opportunities to raise investment from multiple sources

It offers brand protection, confidence in sourcing, and greater credibility.

Provides International Reputation & Recognition, Branding, Credibility and Competitive Advantage.

Potential increase in Business due to enhanced Customer Confidence and Satisfaction.

FDA Registrations ensures the products being tested and found to be safe for public use.

FDA Registration helps to boost the overall business and exports to USA as well as other countries.

Ensures all items sold in the United States meet a pre-defined set of quality criteria.

service portfolio

Our Services Related to USFDA Registration

PRE-AUDIT GAP ASSESSMENT SERVICES

Available across all Management Systems and Standards, Pre-Audits Gap Assessments allow you to Assess your Management System's Readiness and Save your Time and Money that would otherwise be spent on Redundant Audits. A Pre-Assessment Audit is performed with the same independence and objectivity as a Certification Audit.

ADVISORY & CONSULTANCY SERVICES

Quantum Systems has established a reputation for "Building User Friendly, Efficient and Sustainable Management Systems that incorporate Industry Best Practices and that comply with the highest International Standards. Quantum System's provides a 'One-Stop-Shop' for all Social & Technical Management System Consultancy needs.

ACM SERVICES

We can help by designing a Cost-Effective Annual Compliance Maintenance (ACM) Program to suit your Company’s Individual Needs and Expectations. The ACM Services Contract Proposal is based on Parameters like Facility Size, Production Capacity, Workforce Strength, Number of Production Sites and Standards covered in the ACM Contract.

BUYERS COC AUDITS

We provide Advisory Services on Buyers COC Audits for Global Brands like Walmart, Sears, Next, Marks & Spencers, Macy’s, Kohl’s, Levis, Esprit, JC Penny, Adidas, Nike, Carrefour, Li & Fung, Coles, Amazon, ALDI, LIDL, El Corte, Kaufland, ASOS, Bata, Armani, Muller-Meyer, Costco, Nautica, Timberland, Clarks, Inditex, Woolsworth, Clarks, Bunzl, Debenhams, Superdry etc.

TRAINING & CAPACITY BUILDING SERVICES

Our Training Courses cover International and Regional Regulatory Developments, Good Manufacturing Practices, Social & Technical Management Systems Certification, Evolving Technology & Markets etc. We impart trainings on a wide spectrum of courses through different modes like Classroom Trainings, Virtual Trainings, Webinars and eLearning.