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. 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.

 
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.
Biopharmaceuticals including proteins, peptides or monoclonal antibodies and also oligonucleotides or mRNA therapies present multiple challenges to development of an inhaled and nasal administration route for delivery. Our RDD 2022 workshop will address the key concepts, technologies and considerations for involved in building effective OINDP products from a range of biologic APIs. Find out more about our workshop. 

 
 
 
 
 

Need help or have a question?

+44 1763 261648
UK:
+44 1763 261648