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U.S. and Global Regulatory Strategies and Submissions
The Weinberg Group helps clients navigate through the maze of regulation, litigation and public health policy issues that face today's pharmaceutical and biotechnology companies in the successful development of a product or process in the United States, the EU, Japan, and around the world. The following are some of the services we provide in this arena:
- Arrange pre-regulatory filing and guidance meetings with regulatory authorities and prepare FDA and international regulatory meeting briefing documents.
- Prepare regulatory submissions including, but not limited to:
- GRAS notification preparation
- Identification and preparation of experts for GRAS panels
- Convening GRAS panels and preparing consensus documents
- Direct and Indirect Food Additive Petitions
- Color Additive Petitions
- New Dietary Ingredient Notifications
- Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs);
- New Drug Applications (NDAs), Biologics License Applications (BLAs), PreMarket Approval Applications (PMAs) and device Premarket Notification Submissions – 510(k)’s;
- Abbreviated New Drug Applications (ANDAs);
- Marketing Authorization Applications (MAAs) and submissions to other nations;
- Investigator Brochures; and
- Annual Progress Reports in support of new product approvals
- Conformity Assessment Documentation for CE Marking of medical devices for the European market
- Advisory panel presentations and preparation
- Provide overall expert FDA/EPA regulatory consulting
- Assess compliance of labeling and advertising with FDA and FTC regulations
- Prepare substantiation packages for dietary supplement structure function claims
- Prepare substantiation packages for health claims and qualified health claims
- Identify and prepare expert witnesses for FTC, NAD and other proceedings
- Adverse event report (AERs) evaluations
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