Interested to Buy Any Domain ? << Click Here >> for more details...
How to register or submit drug master file to any regulatory agency?
- 2 Answers
- 7010 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / mukesh tiwari
For ANDAs or US Market: One Exhibit or validation batch and
3M stability data.
For EU :Three Exhibit or validation batch and 3 M stability
data. And other supporting documents such as Pre-process
validation protocol and reports, cleaning validation, hold
time study of Bulk, Initial PQ and current one etc.
| Is This Answer Correct ? | 4 Yes | 0 No |
for the register or submit THE DMF of Any TYPE for any regulatory you have to prepare a DMF as per the guideline of the particular regulatory where you wish to submit DMF.
You may get guideline via Internet
for us open pg WWW.USFDA.GOV and search DMF guideline.
and you have to hire a one agent for that.
| Is This Answer Correct ? | 2 Yes | 0 No |
what are the best emulsifying agents used in o/w emulsion
what is the diffirence between deviation and change control? at what situations we can raise the deviation and change control
31 Answers Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic,
Tolerance limit for dissolution media rpm sampling point.
Why 3 validation batches charge in stability ?is there any specific reason for 3 ?
What is the difference between Deviation and Out of Specification ?
Assume that you've been hired for the position. A mother calls and says her child is sick and she needs an appointment this morning. You don't have an open appointment for the morning. What will you do?
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
define process validation
How to preform dissolution profiling
What is difference between Warm and Lukewarm Water as per pharmacopia.
related substances test replicate injection is allow or not if allow so rsd limit how many %?
What is forced degradation study?
Pharmacy 
