Our current and past projects

Developed Stage  Gate Drug System at Manufacturing Science and Technology Group for late-stage development and commercial manufacturing for the treatment of rare diseases 

Developed and implemented a business process and technical frameworks with selection criteria for the selection and management of CDMOs in the USA, EU, India and China for small molecules, biologics, viral vectors and cell-therapy products API and DP. 

Developed framework and KPIs for Portfolio Management and Strategic Planning in Commercial Technical Operations for the projection of annual budget  

Developed project planning for the transfer of two vaccines from early clinical      phase (I/II) to phase III and commercial launch (confidential mid-size      bio/pharmaceutical client

Project  Management for Phase I & II and Manufacturing programs, as well as  process transfer to large pharma company for Phase III and commercial manufacturing

Small molecule API synthesis for Phase 1 clinical trials in the EU 

Small molecule API synthesis for Phase 1 clinical trials in the EU 

Small molecule API synthesis for Phase 1 clinical trials in the EU 

Small molecule API synthesis for Phase 1 clinical trials in the EU 

Small molecule API synthesis for Phase 1 clinical trials in the EU 

Fill-&-Finish facility for sterile drug product manufacturing 

Fill-&-Finish facility for sterile drug product manufacturing 

Fill-&-Finish facility for sterile drug product manufacturing 

Protein nano-particle API manufacturing for Phase 1 clinical trials

Protein nano-particle API manufacturing for Phase 1 clinical trials

Company has successfully manufactured and released DS/DP, filed IND and started Phase 1 clinical trials 

Company has successfully manufactured and released DS/DP, filed IND and started Phase 1 clinical trials 

In-progress

Company has successfully filed IMPD for the Phase 1 clinical trials in the EU 

Lead projects on long-range planning, forecasting, and reporting. 

Developed and led the annual budgeting and quarterly forecasting processes, providing insightful analysis and recommendations to senior leadership. Managed financial reporting, including a monthly comparison of actual vs. budget results and relevant variance analysis to enable organization to deliver on key objectives. Performed trend analysis and scenario modeling to evaluate performance and identify opportunities.