Regulatory


Gmp certificate (2)
Manufacturing License approval on the basis of marketed similar product (1)
Extractable and Leachable study in Dry powder injection in Glass vails type -1 (1)
API In House Specification (5)
Finished product assay limit (2)
Difference between BA BE & Clinical Trials (2)
Same product can be manufacturer at both location (4)
Packaging material (1)
Dry syrup container (1)
Ecommendation for batch size for solution/ granule for suspension dosage from (1)
List of chemicals classified according to OEB levels (1)
Standing Regulatory Members of ICH (1)
Package leaflet (1)
List of submted ANDAs in USFDA (2)
GMP Facility for multiple product (2)
Indian Regulatory - Suppose unapproved drug in India for marketing & manufacturering (4)
Regulatory (0)
Rest of the world (3)
Russian Guideline (2)
Type 1A variation (1)
Product Development Report (1)
Claim of the finished prodct (2)
IT Policy 2017 in Pharma Sector (1)
Certificate of Analysis in GDP (4)
COPP /dossier submission (1)
Dissolution Profile (1)
Pharma HSN COde (1)
Difference between DMF and 32S (2)
Packaging cartons (4)
DMF and Dossier (3)