Regulatory


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)
Standing Regulatory Members of ICH (1)
Package leaflet (1)
List of submted ANDAs in USFDA (2)
GMP Facility for multiple product (2)
Indian Regulatory - Suppose unapproved drug in India for marketing & manufacturering (4)
Regulatory (0)
Russian Guideline (2)
Type 1A variation (1)