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Regulatory Affairs
Specific applications include:
 | Safety (SADR) Regulation Interpretation and Guidance |
| Safety Inspection Guidance (483 avoidance) |
| SOP review for GPVP |
| SOP review for Compliance (483 avoidance) |
| Advisory Committee Preparation Strategies
 | Drug safety issues specific, and/or |
| General guidance |
| Serving as member of MOCK panels |
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| Integrated Summary of Safety (ISS) Development or Review |
| NDA review prior to submission |
| EMEA and MHLW regulation guidance
| including EudraVigilance specifications |
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| ICH guidance interpretation |
Other services:
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