Indications include
- Various oncohematology tumors/basket trials
- Acute Myeloid Leukemia (AML)
- Chronic Myeloid Leukemia (CML)
- Leukemia unspecified
- Myelofibrosis
- Multiple Myeloma (MM)
- NHL
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Follicular Lymphoma (FL)
- T cell Lymphoma
Recent assignments:
- Nonclinical and clinical gap analysis
- Clinical trial development plan and protocol review
- Investigational Brochure (IB) authoring and reviewing
- TTP
- Global regulatory roadmap planning
- Assist in EMA Scientific Advice (SA) for
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- EMA and HTA Parallel Consultation
- Advisory boards
- ODD submission/resubmission
- PIP
- Rehearsal and preparation prior to CHMP oral explanation for a MAA
- PreIND meeting and IND in T-cell lymphoma
- Preparation of FDA Type B/C meetings
- Seek Fast Track Designation (FTD)
30+
Products
50+
Projects
Our Expertise 
