We provide end-to-end commercial manufacturing solutions for Finished Dosage Forms (FDF), ensuring global regulatory compliance, consistent product quality, and scalable supply
Manufacturing Infrastructure
- US FDA, EU GMP, CDSCO, TGA, ANVISA approved sites
- Modern equipment with automated systems
- Capacity details: batch size ranges, production lines
Quality Assurance & Control
- In-process and finished product testing
- Microbiology and analytical labs
- Continuous process verification (CPV)
- Quality Risk Management (QRM)
Regulatory Compliance
- Regulatory filing support (ANDA, NDA, MAA)
- Audit readiness and history of approvals
- Data integrity and traceability systems
- Serialization & Track and Trace (as per global requirements)