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Foreign Regulatory Affairs and Project Management
The following foreign activities are completed in conjunction with REGULIANCE affiliates.
- Preparing, reviewing, and submitting regulatory dossiers
- Compliance auditing of foreign API, drug/biologic, active ingredient, and packaging component suppliers, and contract manufacturers
- Providing regulatory support for foreign facility and systems inspections, including employee behavior training, documentation needs, organization, and inspection planning
- Reviewing non-US regulatory files for due diligence and strategy for acquisitions and in-licensing
Back to Expertise
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Bruce E. Thompson, BSc, MBA
28 Hungerford Terrace
Burlington, VT 05401
(802) 865-0261
bthompson@REGULIANCE.com |
