Human Food & Dietary Supplement Industry
Proconxol offers a wide range of regulatory solutions for the Human Food and Dietary Supplement industry, ensuring compliance with FDA regulations like DSHEA, cGMPs (21 CFR Parts 111 & 117), labeling requirements (21 CFR Part 101), and FSMA. We also support food facility registration, food additives, GRAS determinations, and product standards, providing comprehensive solutions for every stage of the product lifecycle.
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Provide Regulatory Guidance
Development of comprehensive regulatory strategies to support the successful formulation, positioning, and market entry of human food and dietary supplement products. Strategic guidance ensures compliance with FDA and global regulatory requirements throughout the product lifecycle.
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Quality Program Improvement & SOP Management
Optimization of quality systems with a focus on cGMP compliance for human food (21 CFR Part 117) and dietary supplements (21 CFR Part 111). Services include development, review, and implementation of SOPs, quality manuals, and audit readiness programs.
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Labeling & Marketing Compliance
Development and regulatory review of compliant labels, packaging, and promotional materials for food and supplement products. Ensures conformance with FDA regulations under 21 CFR Part 101 and FTC advertising standards, including the use of structure/function and health claims.
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International Product Registration
Preparation and coordination of global registration dossiers for dietary supplements and food products, facilitating market access in the U.S., Canada, EU, Asia-Pacific, and other key regions. Services include regulatory classification, documentation support, and agency liaison.
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Our Services
Post-Market Surveillance & Compliance
Establishment and management of post-market compliance programs, including adverse event reporting, complaint handling systems, product recalls, and regulatory response strategies in alignment with FDA and international guidelines.
Maintain Manufacturing Licenses & Registrations
This service provides support for maintaining up-to-date licenses and registrations required for the manufacturing, labeling, and distribution of human food and dietary supplement products. Assistance is offered to navigate the complexities of state-level requirements, ensuring timely renewals and avoiding potential penalties or disruptions in product availability. This service helps manufacturers stay compliant across all relevant jurisdictions, ensuring continuous regulatory adherence and operational efficiency.
Regulatory Tools & Infrastructure
Implementation of scalable regulatory systems and digital tools, including document control systems, compliance dashboards, and template libraries. Designed to streamline operations and maintain long-term regulatory compliance.
Training & Regulatory Intelligence
Delivery of specialized training programs and ongoing regulatory intelligence to support internal teams. Ensures awareness of evolving regulatory trends, enforcement actions, and best practices relevant to food and supplement industries.
Import/Export Support
Provide comprehensive support for importing and exporting regulated human food and dietary supplement products. Services include drafting and reviewing export documentation, assisting with import permit applications, and offering regulatory guidance for sales teams. Additionally, support is provided for the issuance of Certificates of Free Sale (FSC), Exportability Certificates (CoE), and Foreign Government (CFG) certificates to ensure smooth international trade and compliance.