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.

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.

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.

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.

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.

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.

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.

Proconxol offers Product Certification Assistance, helping manufacturers navigate the certification process for Halal, Kosher, and USP (United States Pharmacopeia) standards. Support is provided to ensure products meet the specific religious, cultural, and quality standards required for each certification. Whether it’s Halal for Muslim consumers, Kosher for Jewish consumers, or USP for quality and purity standards, Proconxol offers expert guidance to ensure successful certification and compliance, enhancing product credibility and marketability.

Provision of experienced regulatory personnel for short- or long-term assignments to support compliance initiatives, audits, documentation, product reviews, and regulatory submissions.

Proconxol offers Product Certification Assistance, helping manufacturers navigate the certification process for Halal, Kosher, and USP (United States Pharmacopeia) standards. Support is provided to ensure products meet the specific religious, cultural, and quality standards required for each certification. Whether it’s Halal for Muslim consumers, Kosher for Jewish consumers, or USP for quality and purity standards, Proconxol offers expert guidance to ensure successful certification and compliance, enhancing product credibility and marketability.

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.

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.