Drug and pharmaceutical licensing encompasses all regulatory approvals required for pharmaceutical manufacturing, distribution, clinical trials, and related activities in the pharmaceutical industry.
These licenses ensure compliance with quality standards, safety protocols, and regulatory requirements for pharmaceutical operations in India.
Essential licenses for pharmaceutical manufacturing and distribution activities
For pharmaceutical manufacturing facilities
For pharmaceutical distribution and wholesale
For clinical research and drug trials
For pharmaceutical testing facilities
For pharmaceutical import and export
For specialized pharmaceutical activities
Regulatory compliance assessment and planning
Complete documentation and dossier compilation
Online portal submission with fees
Regulatory authority facility inspection
Address inspection observations and queries
License approval and certificate issuance
3-6 Months
From application to approval₹50,000 - ₹5,00,000
Based on license type3-5 Years
Renewable with complianceOngoing
Periodic inspections requiredSpecialized team with deep pharmaceutical regulatory knowledge
Strong relationships with CDSCO, State FDA, and other authorities
End-to-end compliance management and documentation support
Fast-track processing with minimal regulatory queries
Get comprehensive pharmaceutical licensing support for your manufacturing, distribution, or clinical trial operations.
