Inhalation Drug Product Development Services

Orally inhaled and nasal drug product (OINDP) development services including CMC support for registration (NDAs/ANDAs), formulation development, GMP analytical testing, product characterisation, stability testing and clinical manufacturing services for small molecule and biologic OINDPs

Inhaled drug product development demands a strategic approach to formulation, analytical testing and device selection to meet requirements for pharmaceutical CMC development and regulatory compliance and optimize product efficacy, quality, safety and performance. 

With 30 years of experience in supporting development of inhalation drug products for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, device verification testing, in vitro bioequivalence testing, CMC support for NDAs/ANDAs and clinical manufacturing services.

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. 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. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory expectations.


Join our RDD Europe 2023 Workshop: How To Build An Inhaler – Navigating New Technologies For Inhaled Product Development To Meet The Ever Expanding Challenges Of Both Small And Large Molecules. Wednesday, May 3 2023

Continuing development of inhalation technologies provides an ever increasing range of device and formulation options to meet the needs of an increasingly diverse range of therapies. There can be many ways to design a product, and all come with different trade-offs for risk, efficiency, stability and performance, which will differ from product to product. The increasing importance of biologics for inhaled delivery has both driven new development and challenged established norms.  Find out more about the workshop. 



Need help or have a question?

+44 1763 261648
+44 1763 261648