Regulatory


Schedule to be written on Label (1)
Weight limits of DPI capsule filling (1)
Need of EP and BP (2)
Any one can suggest how to prepare protocol for analytical method transfer (1)
Storgae condition (5)
Tanzania site registration procedure /guidelines (10)
Comparison between Iso 14385 and Iso 15378 (1)
List of chemicals classified according to OEB levels (2)
Mexico market variation guideline cum notification link (1)
SPC-PIL EU countries (5)
Country requirement Mozambique (1)
Dissolution Profile (2)
New WHO TRS 1010 (2)
Finished Product Stability study to cover all Climatic Zones (3)
Sugar coating variation (1)
COPP Certificates requirment (2)
GMP certificate (3)
Shrinkage of LDPE FFS bottle (1)
Finished product assay limit (4)
Poential genotoxic impurities & genotoxic impurities (1)
Rest of the world (4)
Method transfer (2)
Same product can be manufacturer at both location (5)
Bioavailability of Injectables (4)
Manufacturing License approval on the basis of marketed similar product (1)
Extractable and Leachable study in Dry powder injection in Glass vails type -1 (1)
API In House Specification (5)
Difference between BA BE & Clinical Trials (2)
Packaging material (1)
Dry syrup container (1)