Inhalation drug development expertise across all orally inhaled and nasal drug products (OINDP) including CMC support for registration (NDAs/ANDAs), formulation development, GMP analytical testing, product characterisation, stability testing and clinical manufacturing services for small molecule and biologics.

Inhalation drug development demands a strategic approach to formulation, analytical testing and device selection to meet requirements for pharmaceutical CMC development and regulatory compliance and optimize inhaled drug delivery efficacy, quality, safety and performance. An inhalation route of drug administration presents new and evolving opportunities for the treatment of respiratory diseases including asthma, respiratory infections, chronic obstructive pulmonary disease (COPD) and lung cancer. Furthermore, the field of systemic drug targeting through pulmonary drug delivery is experiencing increased industry focus. However, formulations and devices need to be rationally designed to achieve appropriate aerodynamic properties for effective lung deposition and effective inhalation products.

With 30 years of experience in supporting development of inhaled therapeutics for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, inhaler testing, 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.

3rd Annual Inhaled & Nasal Biologics/DNA Forum

26-27 September 2024 | Cambridge, UK 

Join us for a ground-breaking and insightful forum on inhaled and nasal biologics development: Two days of cutting-edge talks and networking opportunities with leaders in this complex area of inhaled medication and inhaled vaccine development.

An artistic representation of a DNA molecule comprised of dots coloured in shades of white to turquoise against a dark background

Inhalation Drug Product Analysis

Product Development & Characterisation

  • 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

Need help or have a question?

Related Links

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 

Recent News:
Intertek Joins IPAC-RS to Help Drive Innovation in Inhaled Medicines

Contact Intertek