A 513(g) request for information helps clarify FDA device classification and requirements, giving you guidance before choosing a regulatory pathway.
Get practical steps for CAPA system development, from planning and documentation to team training and compliance, in this clear, actionable guide.
Get clear answers on the 510(k) summary—what it is, why it matters, and how to prepare a strong one for your medical device FDA submission.
A GxP gap assessment helps you spot compliance gaps, improve quality systems, and prepare your team for audits with clear, actionable steps.
Get clear on investigational new drug application requirements with practical tips for a strong IND submission and a smoother FDA review process.
Get clear answers about US agent services FDA requires for foreign companies. Learn what a US agent does and how to choose the right partner for compliance.
Get clear, actionable steps for your abbreviated 510(k) submission. Learn requirements, benefits, and tips to help your medical device reach the market.
Get clear, actionable steps for your 510(k) submission. Learn what to include, how to avoid common mistakes, and tips for a smooth FDA review process.
505 pathway consulting helps you save time and resources by guiding your drug through the FDA’s 505(b)(2) approval process with a tailored strategy.
Get a clear, actionable overview of the iso 14971 3.4 risk management plan for medical devices, with practical steps for compliance and safer products.
