Establishment registration with the FDA for supply chain transparency

Pharmaceutical and medical device companies often rely on external suppliers such as Q1 Scientific for the development and production of various components of their products. To ensure the safety and quality of their products, pharmaceutical companies or medical device companies with combination products often require their suppliers to complete establishment registration with the FDA.

At Q1 Scientific, we recognise that completing establishment registration with the FDA indicates to customers that we are aware of and compliant with FDA regulations governing the industry.

Q1 Scientific FDA establishment registration and DUNS number

To store products and support the process for self-identifying with the FDA, Q1 Scientific is both FDA and DUNS registered. An FDA Establishment Identification (FEI) number is a unique identifier issued by the FDA to track inspections of the regulated establishment or facility. A DUNS number is a useful resource for the FDA in identifying and verifying certain business information.

Q1 Scientific’s registration numbers are:

Waterford, Ireland

• FDA Establishment Identifier (FEI), Waterford: 3014125714
• DUNS (Dun and Bradstreet), Waterford: 985524204

Liege area, Belgium

• FDA Establishment Identifier (FEI), Belgium: 3025897478
• DUNS (Dun and Bradstreet), Belgium: 372687966

Supporting customer supply chain transparency by registering with the FDA

One of the key benefits for customers of Q1 Scientific completing establishment registration with the FDA is the assurance of compliance with regulatory requirements and the visibility it gives over the whole manufacturing process.

Outsourcing your stability storage to Q1 Scientific which has FDA establishment registration can provide a range of benefits such as:

1. Confidence in regulatory compliance: You can have greater confidence that Q1 Scientific is complying with regulatory requirements, including Good Manufacturing Practices (GMPs) and other FDA regulations. This can help to reduce the risk of regulatory issues and protect your reputation.
2. Assurance of quality standards: Establishment registration with the FDA requires providers to have robust quality systems in place. Customers can benefit from the assurance that Q1 Scientific is adhering to high-quality standards.
3. Access to expertise: Through FDA establishment registration, Q1 Scientific demonstrates our understanding of FDA regulations and requirements. Customers can benefit from our stability storage expertise and can receive guidance and support on compliance issues. This can be particularly valuable for customers who are new to the market, or who are working with new product types.
4. Improved risk management: Customers can benefit from Q1 Scientific’s risk management processes, which are required as part of establishment registration with the FDA. This can help to identify and mitigate risks related to stability storage compliance.
5. Supply chain visibility: Supply chain visibility is an essential aspect of regulatory compliance in the pharmaceutical industry, and having FDA establishment registration provides our customers with greater visibility over the supply chain of their regulated products.

Commenting on helping our customers avoid potential supply chain issues through FDA establishment registration Catherine O’Brien, Quality Manager at Q1 Scientific says:

“From our experience completing establishment registration with the FDA, improves communication and collaboration between us and our customers and helps to ensure the delivery of safe and effective products to consumers. Full transparency and accountability between us and our customers is important. By registering with the FDA we demonstrate our commitment to compliance and quality, and build trust and confidence with our customers.”

Learn more

To learn more about our commitment to quality and compliance for stability storage talk to our team today.