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.

Inhalation Drug Product Analysis

• OINDP Product Performance Analysis
• IVBE Studies
• Clinical & Finished Product Release Testing
• Extractables/Leachables
• MDRS Particle Studies

Formulation Development

• Nasal Drug Development
• Formulation Development
• Drug Repurposing for OINDP Administration
• Clinical Materials Manufacturing

Product Development & Characterisation

• Product Characterisation Studies
• Device Compatibility Studies
• Device Verification Testing
• Patient In-use / Misuse Studies

GMP Stability Studies

• ICH & Bespoke Conditions
• Temperature Cycling
• Photostability Studies
• Contingency/Disaster Storage

In Vitro Performance Testing 

• In Vitro Bioequivalence (IVBE) Studies
• Comparator Studies
• Dissolution Testing
• Realistic Flow Profiles

Device Experience

• Pressurized Metered Dose Inhalers (pMDI) 
• Nasal Sprays 
• Dry Powder Inhalers (DPI) 
• Nebulizers, Soft Mist OINDPs

Powder and Particle Morphology Studies

• MDRS Particle Size Studies
• Powder and Particle Characterisation
• Laser Particle and Droplet Sizing
• Sub-visible Particle Determination

Inhaled and Nasal Biologic Drug Development
Strengths in both biologic characterisation (ICH Q6B) and assessment of the delivered dose uniformity from device and particle size of the emitted drug

Nasal Drug Product Development Services
We focus on optimization of formulation and device selection & provide in-vitro analysis, integrated with formulation, stability and clinical manufacturing