API Registration

Consulting and Regulatory Services

Anantco is a Mumbai based independent consulting professional company run by experts who specialize in providing consulting services on all DCGI related issues.We provide regulatory services to the Indian & International Pharmaceutical Industry for.

New Drug Approval
API Registration
Biological Registration
Formulation Registration
Medical Device Registration
Cosmetic Products
Clinical Trial Permission

We Specialize in helping our customers
to obtain the following:

Drugs Registration (Form 41)

Vaccines Registration (Form 41)

Medical Devices Registration (Form 41)

Cosmetics Registration (Form 43)

Import License (Form 10)

Test License (Form 11)

New Drug Permission (Form 45)

Hospital License (Form 12AA)

Blood Bank and Blood Product Registration

NOC for Import of Half finished or Raw materials.

Loan License

Legalization of Export/Import documents

Neutral Code License

Any other Organizational Clearances say
Animal Husbandry, Diary Products Etc

Information Regarding any types of Queries
under Drug Rules & Custom Rules.

API REGISTRATION

Requirement :
Dossier as per DCGI Guidelines.
Time Taken :
6 to 8 months

Category Fee

Factory Registration
$10000
Product Registration
$5000 per product
Factory Inspection
( if demanded by DCGI) $25000
New Drug Application
$3500

SCOPE OF THE WORK

Assisting the preparation
of dossier & application
Getting TR Challan.
Review of Dossier
Submission of dossier
at DCGI, Delhi
Updating while testing
of drugs at CDTL
Query Replies from DCGI
Continuous follow up
Maintain Confidentiality &
Anti corruption Laws
Regular updating