Regulatory


Topic Replies Activity
List of chemicals classified according to OEB levels 3 August 16, 2018
Regulatory Audit ( Inspection ) Report of USFDA / EU/ MHRA for Finished product manufacturing site 1 July 28, 2018
USP / BP compliance fo API 2 July 27, 2018
Method of analysis 1 July 27, 2018
Any one can suggest how to prepare protocol for analytical method transfer 2 July 24, 2018
Sitagliptin with metformin tablets 1 July 23, 2018
Basic difference between CEP and DMF in EU countries 1 July 23, 2018
Need of EP and BP 6 July 20, 2018
Which are the points to be review while reviewing the "Validation of analytical procedure" for submmiting in LATAM market? 1 July 20, 2018
Please provide food guidelines for registration Tanzania. I cannot find out in below TFDA website 1 July 20, 2018
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
 

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