Acting as the official US Agent for foreign companies to comply with FDA requirements and other regulatory bodies.
Documentation Preparation
Assisting with the preparation and submission of
documentation needed to appoint Consultare Inc. Group as the US Agent.
Regulatory Compliance Support
FDA Compliance
Providing guidance on FDA regulations and requirements related to the role of the US Agent.
Regulatory Updates
Keeping clients informed about changes in US regulations that may affect their compliance status.
Communication Facilitation
Liaison Services
Serving as a point of contact between the foreign company and US regulatory agencies, including the FDA.
Issue Resolution
Handling communications and addressing any inquiries or issues raised by regulatory bodies on behalf of the foreign company.
Regulatory Filing and Documentation
Submission Assistance
Assisting with the submission of regulatory filings and documentation to US authorities.
Document Handling
Receiving, reviewing, and forwarding regulatory documents and
correspondence from US agencies to the foreign company.
Product Registration and Listing
Registration Support
Assisting with the registration of medical devices,
pharmaceuticals, or other regulated products with the FDA.
Listing Services
Helping with the listing of products and ensuring that all required
information is submitted and up to date.
Regulatory Reporting
Adverse Event Reporting
Assisting with the reporting of adverse events or product
recalls to the FDA or other regulatory agencies.
Periodic Reporting
Managing periodic regulatory reports and updates as required by
US regulations.
Compliance Monitoring and Audits
Ongoing Compliance
Monitoring ongoing compliance with US regulatory requirements and providing updates or corrective actions as needed.
Audit Preparation
Preparing for and assisting with FDA audits or inspections, including documentation and compliance checks.
Training and Education
Regulatory Training
Providing training on US regulatory requirements and the role of the US Agent.
Compliance Workshops
Offering workshops and seminars on best practices for maintaining compliance with US regulations.
Record Keeping
Document Management
Maintaining accurate records of all communications, filings, and documentation related to the US Agent services.
Reporting and Analytics
Generating reports and providing analytics on regulatory compliance status and activities.
Emergency and Crisis Management:
Crisis Response
Assisting with emergency response and crisis management related to regulatory issues or product recalls.
Regulatory Notifications
Managing urgent notifications to regulatory agencies as required by law.
Client Support and Consultation
Ongoing Support
Providing continuous support and consultation to address any questions or issues related to US regulatory compliance.
Strategic Advice
Advising on regulatory strategies and best practices for doing business in the US.
Transition and Exit Services
Agent Transition
Assisting with the transition of US Agent responsibilities if the foreign company changes agents or ceases operations in the US.
Exit Management
Managing the process of ceasing to act as the US Agent and ensuring compliance with regulatory requirements during the transition.
These services help foreign companies navigate the complexities of US regulations and ensure they
remain compliant while conducting business in the United States.
