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SERVICES WHO WE ARE CONTACT RECENT PROJECTS |
Chemistry and manufacturing expertise and experience
◆ Small molecules, peptides, proteins and biologics ◆ Drug delivery and drug-device combinations ◆ Formulation development ◆ Analytical and bioanalytical methods development ◆ Process development
Product development - strategy, planning and execution ◆ Project management, planning and control ◆ SOP writing, document control, internal systems ◆ Selection and coordination of contract research Services ◆ Nonclinical development ◆ Proof-of-concept through IND-enabling studies ◆ Clinical development, clinical trial design and planning ◆ Protocol development and study execution ◆ Nonclinical and clinical trial monitoring and auditing
Regulatory services ◆ Pre-IND packages and IND applications ◆ Orphan drug applications ◆ Medical writing ◆ Regulatory strategy
Business development and specialty services ◆ Sourcing API and manufacturing services in Asia ◆ Development of business plans ◆ Technology due diligence ◆ Scientific support and strategy for patent applications |