Inhalation Drug Development Services
Products & Services
Information
With 30 years of experience in supporting development of inhaled therapeutics for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, inhaler testing, device verification testing, in vitro bioequivalence testing, CMC support for NDAs/ANDAs and clinical manufacturing services. Our laboratories are inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. Our laboratories have also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections.
Our expert formulation development scientists have extensive experience in product development across all categories of inhaled products including dry powder formulations and devices, nebulised solutions/suspensions and metered dose inhalation (pMDI) product types, as well as a range of other novel respiratory delivery systems and drug delivery technologies. Our unique project management approach enables you to interact directly with our expert scientists as the development process advances.
With the largest GMP ICH stability storage facility in Europe, we manage all aspects of stability including storage, long-term and accelerated stability across product's development from early preclinical to commercial batch stability.
https://www.intertek.com/pharmaceutical/analysis/inhalation-product-development/
