Regulatory


eCTD dossier, qos, module 2.4 , 2.5 (1)
DMF, CTD eCTD, Dossier (3)
List of chemicals classified according to OEB levels (3)
Regulatory Audit ( Inspection ) Report of USFDA / EU/ MHRA for Finished product manufacturing site (1)
USP / BP compliance fo API (2)
Method of analysis (1)
Any one can suggest how to prepare protocol for analytical method transfer (2)
Sitagliptin with metformin tablets (1)
Basic difference between CEP and DMF in EU countries (1)
Need of EP and BP (6)
Which are the points to be review while reviewing the "Validation of analytical procedure" for submmiting in LATAM market? (1)
Please provide food guidelines for registration Tanzania. I cannot find out in below TFDA website (1)
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)
Schedule to be written on Label (1)
Weight limits of DPI capsule filling (1)
Storgae condition (5)
Tanzania site registration procedure /guidelines (10)
Comparison between Iso 14385 and Iso 15378 (1)
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)