Indications include
- Multiple sclerosis/demyelinating diseases
- Graft versus Host Disease (GvHD)
- Lupus Erythematosus
- Systemic
- Scleroderma
- Myasthenia Gravis
- Crohn’s disease, ulcerative colitis, celiac disease, inflammatory bowel disease
- Arthritis
- Allergic reactions and hypersensitivity
Recent assignments
- Prepare and submit an ODD in the US and represent the company as US agent
- Prepare a gap analysis, perform CMC IND amendments and prepare BLA modules 3 and 2.3
- Toxicological assessment of 5 leachables
- Prepare and submit a CTA in several eastern European countries
- Provide pre-market PV services in Europe for a clinical trial with a gene therapy product
Products
Projects