DOE-based software with a complete library of design types

Fusion LC Method Development

Automated Quality by Design based LC method development software with rapid multi-column and multi-solvent screening and novel data treatments to minimize manual chromatogram processing. Method optimization includes built-in robustness metrics. Graphical visualization and reporting of multi-dimensional robust Design Space (Method Operable Design Region — MODR) and Proven Acceptable Ranges (PARs). Works with a wide variety of LC systems, and supports both internal and external column/solvent switching valve control. MORE»

Fusion Analytical Method Validation

Complete Analytical Method Validation software system with Early Phase performance characterization and Final Phase submittal-quality validation options. Full experiment suite and LC automation for Small and Large molecule LC methods. Also used successfully for a wide variety of non-LC methods (e.g. QNMR, CE, GC-MS, LC-MS). Analysis and reporting complies with all FDA/ICH Guidances. MORE»

Fusion Product Development

Designed for working scientists and engineers. Supports QbD experiments for development and optimization of formulations, processes, and Non-LC Analytical Methods. Fusion Product Development combines advanced Data Mining with state-of-the-art Design of Experiments (DOE) capabilities. Some of the strategic DOE technologies unique to Fusion Product Development include (1) Global Preferences Settings — Automated mode (novice users) and a User-interactive mode (advanced users) for experiment design and data analysis, (2) integrated Monte Carlo robustness simulation, and (3) Data Mining — examines existing data sets for required cause-and-effect information. If key information is missing, Fusion Product Development can generate extremely efficient "Repair" experiments that provide the required information with minimal additional lab work. MORE»

Fusion Inhaler Testing

Fusion Inhaler Testing (FIT) software module includes all of the analytical results and graphs typically required for Inhalation scientists. FIT automatically generates complete experiment plans for USP Apparatus 1–6 (EP Apparatus A, C, D, and E), and Dose Unit Sampling Apparatuses (DUSAs). FIT builds coordinated LC testing protocols in chromatography data systems (CDS) as ready to run sequences, imports all chromatographic results, automatically computes all results and graphs, and generates a full suite of regulatory aligned reports which meet USP and EP requirements. MORE»

Partial Customer List

  1. 3M
  2. Abbott Laboratories
  3. Acino Pharma AG
  4. Affymax
  5. Alkermes
  6. Amgen
  7. Aptalis Pharma
  8. Astellas
  9. Baxter Healthcare
  10. Becton Dickinson
  11. Biogen Idec
  12. Brystol-Myers Squibb
  13. Cambridge Isotope Labs
  14. CiVentiChem
  15. Covidien
  16. Daiichi Sankyo Co. Ltd.
  17. Dow Agro Sciences
  18. Eli Lilly & Sons, Inc.
  19. Ernest Jackson Labs
  20. Fujifilm Diosynth Biotech
  21. Genzyme
  22. Gilead Sciences
  23. Glaxo-Smithkline
  24. Glenmark Pharmaceuticals
  25. Johnson & Johnson
  26. Johnson Matthey
  27. Kyowa Hakko Kirin Co., Ltd.
  28. Landsteiner Scienific
  29. Lannett Labs
  30. Lundbeck
  31. Malinkrodt/Covidien
  32. Merck
  33. Microsep Pty Ltd
  34. Millennium Pharmaceuticals
  35. Monsanto
  36. Novartis
  37. Novo Nordisk
  38. Otsuka Chemical Co., Ltd.
  39. Pfizer, Inc.
  40. Pharmacyclics
  41. Pharmascience
  42. Procter & Gamble
  43. Prompt Praxis Labs
  44. Protagen AG
  45. Reckitt Benkiser
  46. Sanofi Aventis
  47. Santen Pharmaceuticals
  48. Symphogen
  49. Taiho Pharmaceutical Co.,Ltd.
  50. Takeda Pharmaceutical
  51. Teva Pharmaceuticals
  52. Thales
  53. Tokyo Metropolitan Institue of Public Health
  54. Tsumura & Co.
  55. UCB
  56. U.S. Pharmacopeia
  57. U.S. FDA
  58. Vertex Pharmaceuticals
  59. Watson Pharmaceuticals
  60. Zentiva