Regulatory

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This forum has 22 topics, 49 replies, and was last updated 3 months ago by Anonymous.

Viewing 15 topics - 1 through 15 (of 22 total)

- Topics
- Replies
- Author
- # of Samples Required after transition to CTR
- 1
- By Anonymous
- Clarification on IMP Batches Transitioning from CTD to CTR
- 1
- By Anonymous
- Package Insert
- 2
- By Anonymous
- Testing Methods for Canadian Trials
- 1
- By Anonymous
- Grace period for label changes
- 9
- By Anonymous
- Seeking examples of finished product release documents
- 3
- By Anonymous
- EU guideline on shipping and temp monitoring (536/2014)
- 8
- By Josh Anderson
- Regulatory release of IMP
- 6
- By Amy Thompson
- Comparator references in INDs
- 2
- By Anonymous
- IMP Accountability in IRT & Returns/Destruction @ site
- 7
- By Marla Cordova
- Virtual Finished CT Material Retention Samples
- 3
- By Anonymous
- Annex VI labelling requirements EU/EMA public consultation
- 1
- By Shawn Murtough
- Regulatory – FDA/EMA approval screening
- 1
- By admin@mygcsg.com
- Minimum Shelf Life Requirements for Importation to Asia-Pac
- 2
- By Anonymous
- Keeping Up With Changing Regulations
- 5
- By Anonymous

Viewing 15 topics - 1 through 15 (of 22 total)

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