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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