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.
28-29th September 2023 | Cambridge, UK
This year's conference, centered around the theme of "Building Effective Products," features world-renowned industry leaders who will share the latest insights and case studies in the field of inhaled or nasal biologics and inhaled vaccine development with real-world case studies to stimulate discussion.
Review the list of expert speakers which includes the Keynote Address from Igor Gonda, Founder and CEO, Respidex LLC who will present "Inhaled biologics: What can we learn from Pulmozyme success 30 years later?"
Save your spot for two days of cutting-edge talks and networking opportunities with leaders in this complex area of inhaled biologics and inhaled vaccine development. Registration is live now.
Product Development & Characterisation
- Product Characterisation Studies
- Device Compatibility Studies
- Device Verification Testing
- Patient In-use / Misuse Studies
In Vitro Performance TestingIn Vitro Performance Testing
- In Vitro Bioequivalence (IVBE) Studies
- Comparator Studies
- Dissolution Testing
- Realistic Flow Profiles
- MDRS Particle Size Studies
- Powder and Particle Characterisation
- Laser Particle and Droplet Sizing
- Sub-visible Particle Determination