Regulatory


New product manufacturing (3)
Zone concept ISO 14644 (2)
Top Interview Q & A on Regulatory Affairs (1)
What are the Africa and ASEAN countries? (1)
Major difference of EU and US dossier (1)
Limit of related substances (1)
Indian Patent expiry - Sitagliptin phosphate (1)
Pricing of pharmaceuticals (1)
eCTD dossier, qos, module 2.4 , 2.5 (4)
What are the limitation of GMP in pharma industry (1)
Recommendation for batch size for solution/ granule for suspension dosage form (3)
Cosmetics retail sales (3)
What is the guidelines in the Sudan for registration of cosmetics? (1)
Artworks approval by Regulatory (3)
Anyone here from Pharmacovigilance? (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)