How to register or submit drug master file to any regulatory agency?

Answer Posted / anand patel

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



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

why you are become a medical representative

1681


What are your intentions towards the uplift of the hospital.

1649


How can I assign a retest date for solvents e.g. toluene, methanol, etc?

2520


difference between RF and correction factor?

2336


plz.mail me model papers of drug inspector of chhattisgarh..or MP.if Posible. Mail Id-recha_1428@rediffmail.com...mrs_1428@rediffmail.com,

1964






Caffeine standard is recommended by the monograph for HPLC wavelength accuracy calibration. It is covered range of 205 to 273 only.If the method have wavelength beyond the range, then how it supports for instrument performance?

1193


Why SLS used as dissolution medium

654


when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?

1766


Tell us about a situation in which you took the extra step for a patient.

2786


What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan

1918


what is ur strengths and weekness in ur professional life as medical rep?

2226


What is difference between Warm and Lukewarm Water as per pharmacopia.

1042


concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?

2183


Explain difference between sonication and homozinization?

651


what is the leak test procedure of filled bottles (liquid)

1746