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Inhalation
Testing Services

Expert Understanding of Inhaled Formulation Systems and Device Compatibility

Developing and commercializing new inhaled drug products requires deep scientific understanding through a continuous focus on testing, data collection, and expert analysis. We can help through ‘hands-on’ testing support integrated with consultancy on inhaled product development through all pre-clinical and clinical development stages.

 

 


three scientists in lab coats shaking hands

Flexible OINDP Testing and Development

If you develop, manufacture, or test orally inhaled and nasal drug products (OINDPs), we can help.

Our end-to-end service spans early-stage product characterization and analysis, device selection and testing, and extends to manufacturing validation, cleaning instructions, and small-scale manufacturing. Our consultants have a proven track record in aerosol science, inhaler development, the planning and execution of clinical programs, and successful regulatory filings.

Working with us is like recruiting your own specialist respiratory scientific team. We offer state-of-the-art technologies, general-purpose analytical testing, expertize in device verification testing, and an excellent understanding of inhaled formulation systems and device compatibility.

With years of in-house and consultancy experience in inhalation and aerosol science, device optimization, and novel device regulatory projects, our consultants can give expert guidance on efficient, cost-effective testing approaches for novel products and formulations to ensure regulatory approval.

 

 

Extensive Inhalation Experience 

Our inhalation testing service covers the following product categories.

  • Dry powder inhalers (DPIs)
  • Pressurized metered dose inhalers (pMDIs)
  • Soft mist inhalers (SMIs)
  • Nasal sprays
  • Breath-actuated devices
  • Novel inhaled devices and innovation
3 assorted inhaler devices

Speak to a scientific consultant about your inhalation testing requirements and learn how we can help bring your product to market.

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Our Inhalation Testing Service  

Through a deep technical knowledge of inhalation devices, aerosolization, and formulation science, our inhalation testing service provides the insight you need to bring your inhalation technology device or drug product innovation to market.

Formulation

For dry powder and liquid/ nasal solutions/suspensions, nasal aerosols/powders, and aerosol characterization.
Includes drug repurposing for inhaled or intranasal delivery.
Solution or suspension formulation droplet size and APSD.

Pharmaceutical Analysis and Product Characterization

Spray pattern, leak rate, dose content uniformity, through-life, shot weight, aerodynamic and particle sizing, moisture content, aerosol performance, formulation stability, compendial analysis, and solubility.

Inhaled Device Evaluation, Selection, and Testing

Reference product benchmarking, device robustness testing, priming, and repriming, the effect of varying flow rate, flow rate simulation, device resistance, spacer testing, transportation studies, novel device characterization, simulated patient use studies.

Chemistry, Manufacturing and Control (CMC)

Support spanning all aspects of CMC product development and approval, including manufacturing validation, process development, scale-up, and technology transfer process validation support, temperature cycling, effect orientation during dosing, the definition of cleaning instructions
and small-scale manufacturing  (CDMO/CRDMO).

Benefit from a Fully Integrated Service  

Benefit from our fully integrated testing, consulting, and compliance service that ensures your project can draw on the subject matter experts it needs at every step to troubleshoot, remove bottlenecks, and ensure success. Your projects will be allocated a Technical Project Lead with extensive inhalation industry experience supported by a dedicated Program Manager to ensure proactive communications and smooth delivery of deadlines .

Analytical Method Development, Transfer, and Validation

ICH Q2(R1) analytical method development, method validation, and technology transfer using cutting-edge technology and precision equipment.

 

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Stability Storage and Analysis

On-site storage, study design, and analysis to support a development project, regulatory applications, and post market regulatory requirements with the analytical expertize on hand to advise and troubleshoot.

 

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Extractables and Leachables Testing

In-depth testing and analysis to ensure a full understanding of potential leachable compounds in a container closure system, manufacturing process, or packaging that may impact a raw material, excipient, API, or finished product.

 

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Toxicology Assessment

Guide your medicine from candidate selection to market with in-depth insight into the drug development process through the safety assessment and drug metabolism of your active substance and the toxicology of your excipients and impurities.

 

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Product Realization

Benefit from more informed decision-making through an independent assessment and validation of your product development project.   Save time and money by using this insight to prevent costly reworks later in your project.

 

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Regulatory Support

Access key insights into the most suitable regulatory pathway for your product, get help with troubleshooting regulatory roadblocks, and expert support across the regulatory submission process.

 

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Talk to an expert

Arrange a meeting with a scientific or regulatory expert to discuss your project and learn how we can help to maximize your success.

 

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Inhalation Services Resources 

Learn more about how we can help bring your product to market through our high-quality inhalation testing services.

Pharma-Inhalation-Services

Pharma Inhalation Services

Developing and commercializing new inhaled drug products, requires huge energy and deep scientific understanding. This level of resource and subject matter expertise can be difficult to maintain inside your business, and that is where we can help.

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Whitepaper:-Improving-the-Sustainability-of-Pressurised-Metered-Dose-Inhalers

Whitepaper: Improving the Sustainability of Pressurised Metered Dose Inhalers

Since their introduction in 1956, pressurised metered dose inhalers (pMDIs) have become the dominant treatment choice for patients suffering from common respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). However, unbeknown to most patients and many doctors, pMDIs account for 3.9% of NHS’s annual carbon emissions. 1Here we will discuss how formulation changes might be the answer to the pMDI-related sustainability problem.

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Guide:-Conquering-stability-hurdles-in-pharmaceutical-inhalation

Guide: Conquering stability hurdles in pharmaceutical inhalation

For category innovators thorough stability studies are vital for successful drug development and regulatory approval.

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Technical-Due-Diligence:-Product-Realization-Services

Technical Due Diligence: Product Realization Services

Our product development and regulatory experts can help you meet expectations at key milestones in your product development project to better inform decision making and investment choices.

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Industry Insight and Expert Opinion

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