Regulatory


Topic Replies Activity
Is it necessary to give the Bioequivalence study for the "multivitamins & multiminerals capsules", while registrations in the Kyrgyzstan?If not: Please justify your answer 1 July 20, 2018
Schedule to be written on Label 1 July 18, 2018
Weight limits of DPI capsule filling 1 July 18, 2018
Storgae condition 5 July 14, 2018
Tanzania site registration procedure /guidelines 10 July 12, 2018
Comparison between Iso 14385 and Iso 15378 1 July 12, 2018
Mexico market variation guideline cum notification link 1 July 5, 2018
SPC-PIL EU countries 5 June 22, 2018
Country requirement Mozambique 1 June 19, 2018
Dissolution Profile 2 June 13, 2018
New WHO TRS 1010 2 June 13, 2018
Finished Product Stability study to cover all Climatic Zones 3 June 8, 2018
Sugar coating variation 1 June 5, 2018
COPP Certificates requirment 2 June 5, 2018
GMP certificate 3 June 1, 2018
Shrinkage of LDPE FFS bottle 1 June 1, 2018
Finished product assay limit 4 May 28, 2018
Poential genotoxic impurities & genotoxic impurities 1 May 26, 2018
Rest of the world 4 May 25, 2018
Method transfer 2 May 25, 2018
Same product can be manufacturer at both location 5 May 25, 2018
Bioavailability of Injectables 4 May 25, 2018
Manufacturing License approval on the basis of marketed similar product 1 May 13, 2018
Extractable and Leachable study in Dry powder injection in Glass vails type -1 1 May 12, 2018
API In House Specification 5 May 10, 2018
Difference between BA BE & Clinical Trials 2 April 20, 2018
Packaging material 1 April 5, 2018
Dry syrup container 1 April 5, 2018
Standing Regulatory Members of ICH 1 March 17, 2018
Package leaflet 1 March 10, 2018