Drugs For Manufacturer
At FDA RAQA Solutions, we assist manufacturers in overcoming the challenges of crafting effective regulatory strategies and preparing clear, well-documented dossiers for drug product approval applications. Our team of experts OR trusted associates represent clients at SEC meetings to secure unanimous approvals and permissions. With ongoing regulatory guidance, thorough follow-up and additional services such as clinical trial site management, clinical monitoring and EC submission etc., we help our clients achieve smooth and successful approvals and licensing.
CDSCO-HQ | CDSCO-ZONAL | STATE FDA | |
|---|---|---|---|
INVESTIGATIONAL NEW DRUGS (IND) | TEST LICENSES (CT11/14/15) | WHOLESALE LICENSE | |
NEW DRUGS APPROVAL (NDA) | EXPORT NOC | MANUFACTURING LICENSE (FORM 25/28) | |
SUBSEQUENT NEW DRUGS (SND) | DUAL USE NOC | FORM-29 PERMISSION | |
FIXED DOSE COMBINATION (FDC) | FREE SALE CERTIFICATE | ||
CLINICAL TRIALS (CT) | |||
BE NOC FOR EXPORT | |||
BIOEQUIVALENCE STUDY | |||
TEST LICENSES | |||
PSUR |
Drugs For Importer
At FDA RAQA Solutions, we assist manufacturers in overcoming the challenges of crafting effective regulatory strategies and preparing clear, well-documented dossiers for drug product approval applications. Our team of experts OR trusted associates represent clients at SEC meetings to secure unanimous approvals and permissions. With ongoing regulatory guidance, thorough follow-up and additional services such as clinical trial site management, clinical monitoring and EC submission etc., we help our clients achieve smooth and successful approvals and licensing.
CDSCO-HQ | CDSCO-ZONAL | STATE FDA | |
|---|---|---|---|
IMPORT & REGISTRATION | DUAL USE NOC | WHOLESALE LICENSE | |
MARKETING AUTHORIZATION |
| ||
TEST LICENSE (CT 17) |