Orally inhaled and nasal drug product (OINDP) development services including formulation development, product performance testing, stability, CMC support (NDAs/ANDAs) and clinical manufacturing services
Orally inhaled and nasal drug product (OINDP) development can be challenging. The delivery of drugs by inhaled routes of administration is growing in popularity for local and systemic therapies due to ease of use by the patient, effective drug delivery, and formulation stability. Laboratory testing of orally inhaled and nasal drug products (OINDP) is necessary to determine product safety, efficacy and performance.
With over 25 years of experience in supporting our clients’ product development, we deliver formulation development, product performance testing, stability, CMC support for NDAs/ANDAs and clinical manufacturing services which are designed to provide the right information at the right time.
Our teams of OINDP experts have extensive experience of supporting clients through the inhalation drug product development process. We provide method development and validation, bioequivalence studies, comparator studies, device / excipient compatibility studies, Quality by Design (QbD), formulation development, clinical trials materials manufacturing and product characterisation studies.
With a dedicated ICH stability storage facility integrated with our GMP laboratory testing programs, we manage all aspects of stability study requirements such as ICH and accelerated stability studies, at every stage of a product's development from early preclinical to commercial batch stability.
Intertek's team of expert formulation scientists has extensive experience in product development of inhaled products including all types of 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.
Inhalation Product Development Experience for Product Classes:
Inhalation Drug Product Development Services:
Our inhalation product experts have been working in the inhaled and nasal fields for over 25 years and possess the necessary experience to help design, implement and support full development, stability and testing services which are designed to provide the right information at the right time. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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