CPCSEA Guidelines are used for? Submitted by eswar on Tue, 06/18/2013 - 07:25 Question Category: Regulatory Arrairs
CDSCO stands for? Submitted by eswar on Tue, 06/18/2013 - 07:25 Question Category: Regulatory Arrairs
21 CFR Part 314 gives information about? Submitted by eswar on Tue, 06/18/2013 - 07:24 Question Category: Regulatory Arrairs
As in tradesecret we have rules for not disclosing our formulation receipe. And in case of patent we have to disclose all our formulation factors and it is just for 20 years so why nt. Pharma industry files for trade secret as that is for longer period. Submitted by HITESH CHOPRA on Thu, 03/21/2013 - 12:42 Question Category: Regulatory Arrairs
how the bioequivalence of test compared with the reference product? and what is the limit? Submitted by santhosh fd on Tue, 11/20/2012 - 11:50 Question Category: Regulatory Arrairs
can u plz tell me about regulatory affairs journals. Submitted by Aanilkumar on Sat, 03/10/2012 - 15:42 Question Category: Regulatory Arrairs
Hello, I needed some suggestions from you sir, regarding my M'Pharmacy. I secured a seat in "Drug Regulatory Affairs" in Browns College of Pharmacy. What would be my future aspects after completion & guide me in the correct direction in my future career. Submitted by Govinda Bhattacharya on Thu, 12/08/2011 - 18:09 Question Category: Regulatory Arrairs
What is a orange book??? What does it meant for??? Submitted by Mitul Thekdi on Mon, 05/02/2011 - 18:13 Question Category: Regulatory Arrairs
Regrading Bio equivalence study . UK guidelines(MHRA) Suggest 150ml of water with formulation, whereas USfda requires 240ml with formulation... Submitted by Umachandar l on Wed, 03/23/2011 - 03:32 Question Category: Regulatory Arrairs
I have completed PGDIPR and I want to pass Patent agent examination, can u provide right source so that i can crack this.... Submitted by Ankittyagi on Sun, 03/13/2011 - 07:52 Question Category: Regulatory Arrairs
I want to know types of patents and what are the key points to be considered to avoid infringement of a patent Submitted by nagaajaykumar on Fri, 03/11/2011 - 14:19 Question Category: Regulatory Arrairs
Biopharmaceutical area plan approval is aprroved by? Please help me out with the FDA approval procedure Submitted by Anvar Deen on Wed, 02/23/2011 - 16:42 Question Category: Regulatory Arrairs
what actually does the term regulatory affairs.what the people do in regulatory affairs in industry Submitted by bharathreddy on Tue, 02/08/2011 - 01:13 Question Category: Regulatory Arrairs
what are the sources for reference of non pharmacopoeial substances Submitted by pushpendrajain14 on Sun, 01/09/2011 - 06:59 Question Category: Regulatory Arrairs
WHICH ONE IS HIGHEST REGULATORY BODY IN THE WORLD Submitted by pushpendrajain14 on Sun, 01/09/2011 - 05:28 Question Category: Regulatory Arrairs
If US and UK RLD is same in all respects, is it necessary to do BE with UK sample or US study can be submitted for UK also. Submitted by Sachin Chaudhari on Tue, 01/04/2011 - 05:08 Question Category: Regulatory Arrairs
What are the steps to be taken to prevent illegal running of the pharmacies without having a qualified pharmacist Submitted by kadapala pruthv... on Tue, 11/23/2010 - 08:55 Question Category: Regulatory Arrairs
is colour erythrocin banned by FDA/WHO Submitted by pushpendrajain14 on Sat, 10/30/2010 - 08:07 Question Category: Regulatory Arrairs
What is Referance Listed Drug (RLD) Submitted by pushpendrajain14 on Sat, 10/30/2010 - 05:51 Question Category: Regulatory Arrairs
where can I get the information about Impurities of Ofloxacin other than pharmacopoeial references Submitted by pushpendrajain14 on Sat, 10/30/2010 - 05:12 Question Category: Regulatory Arrairs
Carbapenem Antibiotic Must Have a Separet Aria For Manufacturing From Penicillin and Other Betalactum Antibiotics? Submitted by pushpendrajain14 on Mon, 10/18/2010 - 06:45 Question Category: Regulatory Arrairs
which one is most suitable & most useful Antimicrobial preservative used commonly Submitted by pushpendrajain14 on Sat, 10/16/2010 - 06:43 Question Category: Regulatory Arrairs
Is Butylated Hydroxy anisole banned Submitted by pushpendrajain14 on Thu, 10/14/2010 - 07:24 Question Category: Regulatory Arrairs
is it required to include imprinting ink DMF LOA in to ANDA section 1.4.1-letter of authorization??? Submitted by Hetal Patel on Wed, 10/13/2010 - 03:52 Question Category: Regulatory Arrairs
Why pharmacopoeia recommended microbial testing for Lactose but not for sugar Submitted by pushpendrajain14 on Thu, 10/07/2010 - 13:47 Question Category: Regulatory Arrairs