études stabilité ICH/VICH Cebiphar

ICH / VICH stability studies

CEBIPHAR supports you in your pre- and post-marketing studies: clinical study authorization requests (IND, IMPD), registration dossier (NDA, CTD, safety report, etc.) and post-marketing authorization (on- going stability)

Customized support

CEBIPHAR can fit your needs

  • ICH Storage, VICH Storage, ICH stability study and VICH stability study of active ingredients, bulk, intermediate products and finished products
  • All ICH and VICH storage conditions available: long-term, intermediate and accelerated conditions
  • Binary compatibility studies in support of formulation development
  • Pre-stability studies for the selection of most promising formulation
  • Forced degradation studies
  • In-use stability
  • Freeze / thaw cycles
  • Photo-stability studies
  • Transport simulation studies
Business process

Discover the 4 phases of the life cycle of the analytical method

Interactions process

Our approach

1

Security

Secure storage with qualified back-up storage chambers

2

Compliance

Protocol design (bracketing, matrixing) and approval by our Regulatory Affairs department

3

Expertise

Analysis of samples and management of OOS / OOT with the supervision of pharmaceutical expert

4

Availability

Daily availability to answer your questions about your samples and studies

CEBIPHAR makes every effort to ensure full security of your samples and to emphasize the reporting of trends observed during stability

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