Over-The-Counter Drug Industry
ProConXol provides specialized regulatory consulting services for Over-the-Counter (OTC) drug manufacturers, ensuring compliance with FDA regulations and facilitating global market access. We assist with establishing regulatory strategies, managing product registrations, ensuring labeling compliance, supporting quality system implementations, conducting post-market surveillance, preparing for audits, and navigating import/export regulations. Our goal is to streamline the regulatory process, mitigate risks, and uphold product quality and safety throughout the product lifecycle.
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Regulatory Strategy & Management
Development of comprehensive regulatory strategies to ensure OTC drug products meet FDA requirements and facilitate successful market entry. Support is provided throughout the product lifecycle, from pre-market approval to post-market compliance, ensuring alignment with current regulations.
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Post-Market Surveillance & Compliance
Implementation of post-market surveillance programs to ensure continued compliance with FDA and international regulations. Services include monitoring adverse events, managing product recalls, and maintaining up-to-date reporting and documentation for ongoing market safety.
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International Product Registration
Preparation and management of global registration dossiers for OTC drugs, including submission and compliance with regulatory agencies in markets such as the U.S. FDA, EU, Health Canada, and other international health authorities.
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Labeling & Marketing Compliance
Development and regulatory review of compliant labels, packaging, and promotional materials for OTC drugs, ensuring conformance with FDA regulations under 21 CFR Part 201. This includes managing structure/function claims, active ingredient statements, and claims that are consistent with OTC drug monographs.
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Quality Program Improvement & SOP Management
Optimizing quality management systems for OTC drug manufacturers in accordance with cGMP (current Good Manufacturing Practices) regulations under 21 CFR Part 210 and Part 211. Assistance is provided for the development, review, and implementation of Standard Operating Procedures (SOPs), quality audits, and documentation.
Virtual Regulatory Staffing Support
Providing experienced regulatory professionals on a flexible basis to support high-demand periods or specialized project needs. Virtual staff can assist with documentation, regulatory filings, product reviews, and ongoing compliance efforts.
Marketing & Sales Material Review
Review and regulatory approval of promotional and marketing materials for OTC drugs, ensuring they comply with FDA requirements and avoid misleading or unauthorized claims. This includes structure/function claims, health claims, and other marketing language as defined under 21 CFR Part 101.
Regulatory Tools & Infrastructure
Implementation of regulatory tools, templates, and document control systems tailored to OTC drug manufacturing. Services include compliance dashboards, audit readiness programs, and scalable digital solutions to streamline regulatory processes and maintain long-term compliance.
Maintain Manufacturing Licenses & Registrations
Support for maintaining up-to-date manufacturing licenses and registrations required for OTC drug manufacturing, labeling, and distribution. Assistance is provided to navigate state-level requirements and ensure timely renewals to avoid penalties or disruptions in product availability. This service ensures ongoing compliance with federal and state regulations.
NDC Number Application
Support for the assignment and submission of National Drug Code (NDC) numbers required for OTC drug products marketed in the U.S. This includes preparing and submitting NDC labeler code requests, formatting product listings according to FDA requirements, and ensuring accurate electronic submissions via the FDA’s Structured Product Labeling (SPL) system. The service ensures compliance with 21 CFR Part 207 and proper identification of drug products in the FDA database.