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Therapeutic Areas

Immune System, Connective Tissue, Bone and Joint Disorders

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
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