Animal Health Product Industry
ProConXol delivers specialized regulatory consulting for the animal health care industries, offering strategic guidance across product development, regulatory submissions, and market compliance. Services include regulatory pathway assessment, product registration, labeling and claims compliance, quality system implementation, audit readiness, and import/export regulatory support. Expertise spans non-medicated and medicated feed, pet food, and animal health care products, ensuring alignment with FDA, AAFCO, NASC and state-level requirements to facilitate efficient market entry and sustained regulatory compliance.
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Our Services
Training & Regulatory Intelligence
Offer customized training programs for regulatory affairs, quality assurance, and operational teams to ensure up-to-date knowledge of current regulatory requirements and best practices. Providing real-time regulatory intelligence updates helps teams navigate audits and inspections confidently, staying informed about changes in regulations and enforcement actions.
Regulatory Strategy & Management
Develop customized regulatory strategies to facilitate global market access for animal health products, including veterinary medicines, medicated feeds, and pet foods. Services encompass product classification, determination of regulatory pathways, and preparation for pre-submission meetings with regulatory authorities. Strategic planning ensures alignment with regional requirements, streamlining the approval process across various markets.
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Labeling & Marketing Compliance
Review and develop labeling, packaging, and promotional materials to ensure adherence to regulatory standards and accurate representation of product claims. Services include verifying compliance with language requirements, as seen in Canada’s Veterinary Health Products (VHP) regulations, and ensuring alignment with regional regulatory requirements, such as the FDA’s labeling rules and the EU MDR/IVDR Annex I requirements.
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Post-Market Surveillance & Compliance
Design and implement post-market surveillance programs to monitor the safety and efficacy of animal health products post-launch. Services include adverse event reporting, complaint handling systems, recall coordination, and preparation of Periodic Safety Update Reports (PSURs). Ensuring ongoing compliance with regulatory standards safeguards public and animal health.
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Quality Program Improvement & SOP Management
Support the development and enhancement of quality management systems (QMS) in compliance with Good Manufacturing Practice (GMP) standards. Services include creating and reviewing Standard Operating Procedures (SOPs), conducting internal audits, implementing corrective and preventive actions (CAPA), and performing regulatory gap assessments to strengthen compliance and operational efficiency.
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Review and Approval of Marketing and Sales Materials for Compliance
Ensure marketing and promotional content for animal health products complies with global regulatory requirements. Services include thorough reviews of websites, digital media, print advertisements, and other materials to confirm that claims are substantiated, appropriate for the intended audience, and free from regulatory risks.
Maintain Manufacturing Licenses & Registrations
Assist in acquiring and maintaining required manufacturing licenses and registrations across various jurisdictions. Services include obtaining FDA Establishment Registration and Device Listing, state-level licensing, EU Authorized Representative and importer registrations, and managing ongoing renewals to ensure uninterrupted operations and market access.
Regulatory Tools & Infrastructure
Implement and manage digital tools and infrastructure to support regulatory compliance efforts. Services include deploying electronic Quality Management Systems (eQMS), document control systems, compliance tracking dashboards, and ready-to-use templates for technical files, risk management, and post-market surveillance documentation. Scalable solutions streamline compliance processes and improve audit readiness.
Virtual Staffing Support
Provide flexible virtual staffing solutions to augment internal teams with experienced regulatory professionals. Support includes documentation preparation, technical file development, labeling reviews, regulatory submissions, QMS implementation, and audit assistance. Ideal for addressing short-term needs, managing ongoing projects, or rapidly scaling regulatory capacity.
Import/Export Support
Assist with navigating import and export regulations for animal health products, including obtaining necessary permits and ensuring compliance with international standards. Services include drafting and reviewing export documentation, assisting with import permit applications, and providing regulatory support for sales teams. Additionally, services encompass the issuance of Certificates of Free Sale (FSC), Exportability Certificates (CoE), and Foreign Government (CFG) certificates to facilitate smooth global distribution and market access. Expert guidance ensures adherence to regulations set forth by authorities such as the FDA and USDA, streamlining the international trade of veterinary medicines, medicated feeds, and pet foods.