|
Export dossier for cambodia registration
|
|
0
|
444
|
April 23, 2021
|
|
Biological product
|
|
1
|
522
|
April 20, 2021
|
|
Stability study to establishing of retest date
|
|
0
|
530
|
March 10, 2021
|
|
Clopidogrel tablets
|
|
0
|
436
|
March 4, 2021
|
|
Regulatory Query on Analytical Methods
|
|
0
|
704
|
February 19, 2021
|
|
Regulatory Requirements for conduct clinical trials in USA
|
|
2
|
1477
|
February 18, 2021
|
|
Registration and quality issue
|
|
0
|
423
|
February 15, 2021
|
|
Work in Process
|
|
0
|
479
|
January 14, 2021
|
|
Import registration
|
|
3
|
755
|
December 23, 2020
|
|
Regulatory compliance
|
|
2
|
651
|
December 20, 2020
|
|
WHO-GMP REGARDING
|
|
2
|
648
|
December 7, 2020
|
|
Type 1A variation
|
|
1
|
879
|
November 20, 2020
|
|
CMC for IM product by chemical synthesis
|
|
0
|
469
|
November 7, 2020
|
|
Variation of PIL necessary or not?
|
|
0
|
449
|
September 24, 2020
|
|
GMP Facility for multiple product
|
|
2
|
696
|
July 25, 2020
|
|
Separate-manufacturing-facility-for-penicillin-and-non-penicillin-products
|
|
1
|
756
|
June 16, 2020
|
|
Common Technical Document
|
|
0
|
486
|
May 11, 2020
|
|
Impurities Calculation
|
|
0
|
570
|
April 29, 2020
|
|
What are the limitation of GMP in pharma industry
|
|
1
|
674
|
April 28, 2020
|
|
Dissolution study
|
|
1
|
725
|
April 28, 2020
|
|
Stability studies for hand sanitizer
|
|
2
|
858
|
April 28, 2020
|
|
Analytical method validation, DMF, specification, product development report
|
|
0
|
627
|
April 10, 2020
|
|
API or excipient specification by drug product manufacturer
|
|
0
|
503
|
March 26, 2020
|
|
Daily dose of sanitizer?
|
|
1
|
636
|
March 24, 2020
|
|
HAND SANITIZER UNDER COSMETIC OR DRUGS
|
|
1
|
585
|
March 17, 2020
|
|
Example of LOA for Type III DMF Holder
|
|
0
|
475
|
February 26, 2020
|
|
Good Laboratory Practices (GLP)
|
|
2
|
635
|
February 17, 2020
|
|
ASSAY limits for products under Stability
|
|
5
|
1141
|
February 14, 2020
|
|
Open part of DMF(USDMF)
|
|
0
|
606
|
February 3, 2020
|
|
Standing Regulatory Members of ICH
|
|
1
|
1270
|
January 28, 2020
|