CNC provides assistance on FDA import issues to international and U.S.A. industries & services, trade associations, the legal profession, and non-profit advocacy organizations.

CNC and associates have regulatory and technical expertise to

• Assist with developing business plans to import FDA regulated products to the U.S.A. market by identifying FDA requirements and methods to achieve compliance with the requirements before and after shipment of products. The products include human and animal foods, human and animal drugs, medical devices, pharmaceuticals, cosmetics, and biologics;

• Assist businesses develop problem-solving strategies to handle FDA-related crises including FDA Import Alerts, detentions, refusals and other related compliance issues;

• Assist with the development of FOIA requests and appeals for FDA records and information relevant to a business or organization’s mission statement or project;

• Assist with development of software requirements and business practices related to risk management approaches for international supply chains delivering safe imported FDA regulated goods;

• Provide customized training on FDA import operations and procedures and regulatory requirements;

• Provide litigation support for administrative, civil and criminal cases related to laws and regulations enforced by or having jurisdiction over the U.S. Food and Drug Administration.