Product Realization

Independent advice, evaluation, and verification of new product technology and innovation

Helping inform key investment and development decisions around a new technology or innovation, device hardware, drug/device combinations, or a product’s readiness for regulatory approval through our extensive technical understanding and industry-specific expertise. Insight from a range of experts across engineering, scientific consultancy, technical writing and regulatory compliance will help move a project forward or ensure costly mistakes are avoided early on.

Helping Guide Your Innovation Through to Commercialization

Advice on functional and regulatory requirements for a new or existing product/technology.
Scoping of test methods and assessment activities to verify and validate a product.
Consulting on product improvements and optimization to comply with regulatory requirements.
Review or creation of Technical Documentation required for regulatory submission.
Technical Due Diligence service package giving 'a quick assessment' of a product or technology.

Verification and Validation

Once the functional and regulatory requirements for your new product or technology have been determined, the next step is to demonstrate compliance. We create bespoke test methods and assessment activities tailored to your individual product needs to enable independent verification and validation. This pre-compliance evaluation will identify any areas of concern and allow for both the product and test methods to be optimized to ensure final compliance is achieved.

Product Improvements and Optimization

A pre-compliance evaluation may often highlight areas that need addressing for the product to meet the identified functional and regulatory requirements. Consulting support from our engineering, scientific, and regulatory compliance experts will provide options for improvement and optimization. Such improvements may include a change of material or formulation, design modifications, alternative manufacturing processes, or updates to technical documentation.

Technical Documentation

For a product to comply with regulatory requirements, there are a significant number of technical documents that must be provided. With extensive experience and expertise in this area, our consultants can review existing documentation and advise on what gaps need filling to ensure a successful regulatory submission. This extends beyond regulatory requirements, ensuring the relevant technical detail is provided for manufacturing scale-up to guarantee the consistent quality of your final product.

Our Technical Due Diligence Service Package

A quick product or technology assessment is often required to help with decision-making. Validating technology acquisition, investment decisions, or the next steps in product development requires access to a variety of industrial and scientific subject matter experts with insight and experience. Help inform your decision-making through our quick assessment Technical Due Diligence service package, which will give you and your team the initial insight needed to make investment choices around resource allocation or the next stage in development.

Product Assessment

Including a specification review, bill of materials assessment, and evaluation of design documentation to give an independent analysis of your product's readiness for regulatory submission, investor meeting, or next stage of development.

Click here to read more about our product assessment testing.

Product Market Review

Identifying competitors and reviewing their products. Evaluating your product's points of differentiation and unique selling point (USP). Confirming the right regulatory pathway to bring your new product to market.

Product Tear Down

Evaluating your product or prototype to understand the components and materials' development status. Analyzing if these are suitable for mass manufacture and commercialization in a finished product. Confirming if the product is ready to start the regulatory submission process.

Manufacturing Assessment

Reviewing the processes and materials across the proposed manufacturing process. Evaluating the Cost of Goods (CoGs) and giving expert advice on the proposed supply chain for a new product.

Functional Testing

Evaluating current product performance and measuring this against competitor products to gain insight into where improvements should be made to make your product more competitive.

Toxicological Assessment

Ensuring all materials and ingredients have been screened for potential hazards. Conducting toxicology data reviews for carcinogenic, mutagenic, and reprotoxic (CMR) risks from chemical substances. Advice on potential alternative ingredients and materials to consider to reduce the risk profile of the product.

Click here to read more about our toxicology assessment services.

Stability Testing

Creation of a suitable stability testing plan to give a full evaluation of the stability profile of a finished product or specific ingredient. Includes real-time, accelerated, and forced degradation stability studies with expert analysis and advice on-hand to help address concerns about a product's stability.

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USP Testing

Verification of a product's Unique Selling Point (USP) claims to ensure they are supported by research and are aligned with customer benefits.

Product Realization Benefits

An independent, objective review and validation of products or technology at any stage of development,
A scalable solution to meet your individual needs with services offered as standalone modules.
Industry and regulatory expertise in compliance and market readiness.
One integrated team of experts to accelerate the project and deliver insight quickly.
Reduced costs and increased speed by making the right decision and avoiding costly mistakes, delays, or reworks later.

Consultancy Services Resources

Learn more about how we can help bring your product to market through our scientific and regulatory consultancy 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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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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Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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