Reg_Information Archives - Page 3 of 3 - Medical Devices and Pharma

Regulatory Documentation for National and Global Market Access

by Bruce Waldon | Jan 3, 2023 | EU MDR, FDA Approvals, FDA Regulations, Global-RA, Med-Devices, Pharmaceuticals, Reg_Information

With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.

FDA Information – Conveniently Organized and Accessible

by Bruce Waldon | Dec 31, 2022 | Consumer Information, FDA Enforcement, FDA Public Information, Industry News, Med-Devices, Pharmaceuticals, Product-Innovation, Reg_Information, US-FDA

FDA Information - Conveniently Organized and Accessible Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Quickly find the FDA information you need Conveniently organized FDA information. The U.S....

FDA Announces Online Electronic 510(k) Submissions

by Bruce Waldon | Dec 18, 2022 | Med-Devices, Reg_Information, US-FDA

The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...

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