Regulatory & Quality Compliance

Navigating regulatory laws can be complex, requiring expert review of available data and risk.

Increase your company’s credibility and integrity

We estimate that approximately 30-40% of dietary supplements produced each year may not fully comply with regulatory guidelines, underscoring the need for stringent quality control and adherence to safety standards across the industry.

We are proud of our extensive achievements in regulatory and quality compliance. We resolve thousands of complaints annually for major multinational corporations and continuously improve hundreds of formulations for our clients. Our Regulatory and Quality Compliance service is designed to ensure that all standards are met, offering comprehensive support throughout the product lifecycle.

Our services include:

Document Control – Comprehensive document dossiers prepared for your product, meeting all compliance standards.

SOP Development – Establishment of compliant processes tailored to your operations.

Claims Substantiation – Validation of product claims through robust data and scientific research.

Stability Testing – Coordination of stability tests to assess and ensure product shelf life.

Supplier Qualification – Qualification and ongoing monitoring of suppliers to maintain quality and consistency.

QMS Implementation and Optimization – Deployment of Quality Management Systems that enhance product quality and regulatory alignment.

Label and Compliance Review – Ensuring that product labeling meets all regulatory standards.

GMP Audits (Coming Soon) – Audits to confirm Good Manufacturing Practice (GMP) adherence.

Training Programs – Training sessions to educate teams on compliance and best practices.

Risk Assessment – Identification and evaluation of potential risks to ensure product safety.

CAPA Management – Corrective and preventive actions to address quality issues proactively.

Product Life Cycle Management – Comprehensive oversight from product development through to market delivery.

Our Regulatory and Quality Compliance services are designed to help you navigate the complexities of compliance and establish a robust foundation for quality and safety in every product.

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