At Avendium, we delive strategic regulatory support to help you navigate submissions, meet global requirements, and bring products to market faster.
Regulatory Strategy Development
Our regulatory strategy development service is designed to navigate the complex landscape of quality assurance and regulatory affairs, ensuring that your product meets all necessary standards and regulations for market entry. Leveraging extensive expertise and a deep understanding of both local and international regulatory frameworks, Avendium provides tailored guidance to optimize your regulatory pathway. We assist in identifying the most effective submission strategies, preparing regulatory documentation, and interfacing with regulatory bodies.Â
Regulatory Submission Management
With a focus on precision and compliance, our experienced team meticulously prepares, reviews, and manages all aspects of the submission process. We streamline the submission workflow to reduce delays and enhance efficiency, providing expert guidance on the format, content, and timing of submissions. Our proactive approach helps you navigate through complex regulatory landscapes, ensuring timely approvals and market access, while keeping you informed and prepared at every step.
Pre-Clinical & Clinical Trial Regulatory Support
Our team offers expert guidance throughout the entire trial process, from initial regulatory strategy and study design to the final submission of trial results. We prepare and review all necessary documentation, coordinate effectively with regulatory bodies, and maintain adherence to all clinical regulatory requirements. By addressing potential hurdles early and upholding rigorous compliance, we aim to accelerate your product’s path to market, reduce the risk of regulatory setbacks, and support successful trial outcomes.
Labeling/Packaging Compliance
Our product labeling team conducts comprehensive reviews to verify compliance with both domestic and international regulations. We provide expert guidance on design to ensure that your labels and packaging are not only compliant but also user-friendly and effective. Additionally, we manage potential risks by proactively identifying and addressing compliance issues. We keep you updated on regulatory changes and facilitate communication with regulatory authorities to streamline approvals. Our firm also offers training for your staff to maintain ongoing compliance.Â
Quality System Compliance
We evaluate and enhance quality systems to meet the specifications set by regulatory bodies such as the FDA, EMA, and ISO. Our experts assist in implementing robust quality processes that include documentation practices, internal audits and corrective and preventive actions (CAPA). We also provide training for your team to effectively manage and maintain these systems. By optimizing your quality system, we help you minimize compliance risks, improve operational efficiency, and ensure continuous improvement in product quality and safety.
Post Market Regulatory Support
We provide ongoing surveillance and reporting assistance, including managing adverse event reporting and handling product recalls if necessary. Our team supports updates and modifications to your product, verifying all changes comply with current regulatory standards. Additionally, we offer guidance on maintaining compliance with evolving regulations and conducting post-market clinical follow-up studies.
Medical Device Regulatory Services
We perform device classification, risk assessment, and compliance with both U.S. FDA regulations and international standards, our team confirms your products meet all necessary requirements for market entry and sustained compliance. We assist with the preparation and submission of pre-market notifications, registration, and compliance documentation. Additionally, we provide ongoing support for post-market surveillance and quality system management.
Pharmacovigilance
We provide robust monitoring and reporting systems to detect, assess, and prevent adverse effects and other drug-related problems. Our team assists with the creation and management of safety data, the preparation of periodic safety update reports (PSURs), and the submission of mandatory regulatory filings. We also offer strategic advice on risk management and mitigation strategies.
Compliance with International Standards
We provide expert guidance on navigating the complex web of international regulations and standards, such as ISO, IEC, and specific national directives relevant to your industry. We assist in adapting your compliance strategy to various regulatory environments, assuring your documentation, processes, and products are in line with international norms. This service not only facilitates smoother market entry across borders but also enhances the credibility and quality assurance of your offerings worldwide.
Regulatory Compliance Audit
We delve into your company’s operations, reviewing documentation, processes, and controls to identify any compliance gaps. By utilizing a mix of on-site evaluations, staff interviews, and a thorough review of regulatory submissions and internal records, we provide a detailed assessment and actionable insights. This in-depth analysis helps us guide you towards implementing robust corrective actions, enhancing compliance, and maintaining ongoing adherence to all pertinent regulations, ultimately supporting your company’s integrity and market success.
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