American Technical Consultants
When Direction Matters
Regulatory Affairs
Strategies for Interfacing with Regulatory Authorities
Compliance Abatement
ATC delivers:
The expert consultants at ATC provide counsel and support in:
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Evaluation of technologies and markets
- Strategic planning
- Development of optimal organizational operations
- Project review and coordination
- Development, scale-up and documentation of production schematics
- Compliance with QSR, GMP and ISO standards
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Qualification and validation of facilities and operations
- Creation of regulatory strategies
- Creation and filings of all necessary documents
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All aspects of product and plant registration, including:
- Preparation for FDA inspections
- Interactions, at every level, with regulatory agencies, including responses to Warning Letters.
Compliance Abatement
ATC provides organizations with expert advice for the promotion of a project, or the development of a corporate strategy.
ATC delivers:
- FDA Form 483 Observations
- Warning Letter
- Product Recalls
- Import/Export Issues
