Pulmonary And Nasal Device Analytical Services

Pharmaceutical and biopharmaceutical companies developing products for nasal and pulmonary dosage forms can mitigate the risks of product development by relying on a trusted resource that provides reliable analytical data and total project management. West Analytical Services is a preferred outsourcing partner for clients that require consultation and full project management for testing delivery devices for pulmonary and nasal dosage forms.

West offers cGMP-compliant analytical testing studies of horizontal and vertical actuated dry powder inhaler products for Chemistry, Manufacturing and Controls documentation (CMC). West's professionals understand their clients' specific testing needs and will create a customized program, including method development and method validation, to meet requirements for:

• The Guidance for Industry, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products– Chemistry, Manufacturing and Controls Documentation.
• The appropriate stability storage conditions.
• Interpreting test results, generating custom reports and delivering a Certificate of Analysis (CoA) or in a format consistent with the CMC section of an Annual Report.
• Long-term stability studies (both developmental and validation/biobatches) including studies of potent compound products.