GXP Consultants, through our relationships with more than fifty technical and legal experts, can provide you with access to virtually every legal service needed to clients in industries regulated by the United States Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and their regulatory counterparts in Europe and other countries. Examples of such services include but are not limited to the following:
- Counseling Clients on specific regulatory issues as well as broad strategies for development and market authorization of pharmaceutical, biotechnology, medical device and diagnostic, Active Pharmaceutical Ingredients (API) , nutritional supplements, etc.
- Counseling clients on requirements and proposed requirements of regulatory agencies around the world.
- Representing Clients in various types of litigation such as FDA or USDA related seizure, injunctive, regulatory, and criminal actions as well as challenges to administrative actions under the Administrative Procedure Act (APA)
- Reviewing labeling and advertising copy for regulated products
- Responding to FDA Form 483 Inspectional Observations, and assisting in connection with warning letters, recalls and other FDA or USDA compliance actions
- Representing companies and trade associations as to rulemaking, petitions, and other administrative proceedings before FDA, USDA and other agencies
- Representing companies and trade associations in legislative matters before the U.S. Congress
- Counseling and representing companies and trade associations when regulators in the U.S. or other countries are considering or implementing legislation or regulations that would affect their products
- Preparing summaries and analyses of other countries' laws and regulations, as well as international standards and agreements
- Providing advice on how the requirements of the World Trade Organization (WTO), the North American Free Trade Agreement
(NAFTA) and other trade agreements have an impact on regulations governing food, drugs, cosmetics, medical devices, and other consumer products
- Representing Clients in international conferences and meetings
- Providing advice on the United Nations (UN) Food Standards Program (Known as Codex Alimentarius Commission), the Organization for Economic Cooperation and Development, and other international organizations whose work affects industry clients
- Crisis management using expertise legal and process expertise for foodborne disease outbreak, recall of company products, tampering or threatened tampering with a product, initiation of an enforcement activity by the government, natural disasters etc.
13681 Newport Avenue
Tustin, CA 92780