Quality and Regulatory

At Shield, maintaining the highest standards of quality and regulatory compliance is at the core of everything we do. Our commitment to excellence ensures that every product we manufacture meets or exceeds the expectations of our customers and regulatory agencies. From raw material sourcing to final product packaging, our rigorous quality control processes and adherence to industry-leading standards ensure that each product is safe, effective, and compliant.

FDA Registration and cGMP Compliance

Our manufacturing facilities are FDA-registered and operate in full compliance with current Good Manufacturing Practices (cGMP), as outlined by the U.S. Food and Drug Administration (FDA). These practices are essential to ensuring the consistent production of high-quality pharmaceutical and consumer healthcare products. We adhere to the highest levels of sanitation, safety, and quality at every stage of production, from initial formulation to final packaging.

Our facilities are designed to meet stringent regulatory requirements, and we conduct regular audits and inspections to ensure that we are always operating at the highest standard. Our commitment to cGMP means that all processes are documented, controlled, and validated to maintain the integrity of every batch we produce. This focus on quality and compliance guarantees that our products are safe for consumers and meet all regulatory guidelines set forth by the FDA and other authorities.

UL Certification

In addition to FDA registration and cGMP compliance, Shield’s facilities are UL-certified. UL, or Underwriters Laboratories, is a global safety certification organization known for its rigorous standards in product safety and quality. Our UL certification ensures that our products are manufactured in accordance with the highest safety and quality standards, ensuring reliability and consumer confidence in our products.

21 CFR Part 210 and 211 Compliance

Shield operates in full compliance with 21 CFR Part 210 and 211, which govern the manufacturing, processing, packing, or holding of drug products. These regulations set forth the requirements for current Good Manufacturing Practices (cGMP) to ensure the quality, safety, and efficacy of pharmaceutical products. Our adherence to these regulations ensures that every step of the production process, from raw material testing to finished product release, is meticulously controlled.

21 CFR Part 210 outlines the general requirements for pharmaceutical production, while Part 211 delves into more specific requirements for cGMP in the manufacturing, processing, and packaging of drug products. Compliance with these regulations is non-negotiable and integral to our business, and we continuously invest in maintaining the highest standards of cGMP, quality assurance, and regulatory compliance.

Commitment to Continuous Improvement

At Shield, we understand that quality and regulatory standards are not static—they are ever-evolving. As such, we are committed to continuous improvement and invest heavily in training our staff, upgrading our facilities, and staying current with changes in industry regulations. This proactive approach ensures that we remain at the forefront of the industry, delivering high-quality products that meet the needs of our clients and the requirements of regulatory authorities.

Whether it’s ensuring that our products comply with FDA guidelines, meeting the highest standards of cGMP, or maintaining UL certification, Shield’s dedication to quality and regulatory excellence is unwavering. We work diligently to ensure that every product we manufacture is safe, effective, and compliant, ensuring peace of mind for our clients and end consumers alike.