– Pre-formulation studies and API characterization
– Target product profile (TPP) development
– In silico and in vitro assessments for drug viability
– Formulation screening and optimization for lead candidates
– IND-enabling studies and regulatory support
– Scale-up manufacturing and technology transfer
– GMP production for Phase II and III clinical trials
– Analytical method development and validation
– Stability studies and ICH-compliant testing
– Process validation and regulatory submission support
– Large-scale GMP manufacturing for market supply
– Quality control testing and batch release
– Regulatory compliance with global market requirements
– Lifecycle management and continuous process improvement
– Supply chain and distribution support for commercial products