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.

 

Inhalation Drug Product Analysis
Product Development & Characterisation
  • Product Characterisation Studies
  • Device Compatibility Studies
  • Device Verification Testing
  • Patient In-use / Misuse Studies
GMP Stability Studies
In Vitro Performance Testing
In Vitro Performance Testing 
  • In Vitro Bioequivalence (IVBE) Studies
  • Comparator Studies
  • Dissolution Testing
  • Realistic Flow Profiles
Device Experience
Device Experience
OINDP Particle and Powder Characterisation 100
Powder and Particle Morphology Studies
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

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Related Pages

In Vitro Test Methods for Nasal Drug Products - Part1 - AINI
Intertek Melbourn - 30+ Years Experience in Drug Development
Intertek Melbourn

GMP Pharmaceutical Analysis and Formulation Expertise

Intertek Melbourn
Saxon Way, Melbourn
Herts, SG8 6DN 
UK

Recent News:
Laboratory Expansion for Specialist OINDP Development for Biologics