Pragmatic Innovation Ltd
- North America
- Human Medicines, Biopharmaceuticals, …
- Service category
- Pharmaceutical process development and validation, Partnering/collaboration for drug dossiers, patents, drug candidates, medical technology, …
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Product companies need to constantly innovate to stay ahead of the competition and to add value to their brands. Differentiation is the key and the challenges are getting harder and harder.
PiL is driven by a philosophy which ensures that the supply chain, the manufacturing, assembly and testing methods are considered alongside the development of the product. The world’s best product is worthless if it cannot be made economically. PiL has experience of assisting multinational clients to develop world beating products with associated manufacturing processes and comprehensive supply chain.
We understand that risk reduction and pragmatic innovation through feasibility testing is a vital first step in product development.
With every project we will take time to understand the product needs and to establish the best method of manufacture, applying:
Design For Manufacture (DFM)
Failure Modes and Effects (FMEA or FMECA)
Knowledge of product development in the medical regulatory environment – with ISO9001 and ISO1348-compatible processes in place
Staff with many years of corporate experience in the medical and healthcare sector combined with business strategy expertise
PhD-qualified staff in the areas of physics, mathematics, chemistry, biochemistry, molecular biology and materials
PiL has established a personal relationship with a number of the suppliers worldwide and specialises in supply chain strategy for companies looking to launch new products and improve sharholder value for existing products.
PiL has decades-worth of experience in creating, developing and optimising complex processes for industrial. FMCG, Medical and Pharmaceutical clients
Our development pathway runs from Concept Development through to Implementation. These are usually completed as a series of steps.
- Process Optimisation
- Process troubleshooting
- Product development
- Product realisation
- QA testing automation
- Machine design
- Packaging development
- Technology project management
- Due diligence
- Expert witness
- Patent circumvention
- Innovation management
All our processes meet EN60204 and 93/68/EEC (CE Marking). Pharmaceutical processes can be developed to GAMP 5.0 if required or better still ASTM E2500-07 - in any case a Quality Plan is an integral part of defining the pathway and enabling compliance. Compliance with ISO13485 is applicable for small machines with an expectation of replication
Adrian Howson is a Fellow of the Institute of Mechanical Engineering, a Chartered Engineer and holds an MBA from City University Business School (now CASS). He has over thirty years of professional engineering experience, and has worked on a number of expert witness cases since the early 1990s
Adrian's expertise includes mechanical engineering, process and product design and testing, machine design, patent and design right disputes, mechanical forensics, breakdown and failure analysis, manufacturing issues and the investigation of personal safety issues.
He has access to a number of experts in technology and scientific disciplines allied to engineering and can provide test and investigative resources through the University of Cambridge and a number of technology and engineering consultancies in the region.
He has presented many papers at conferences and is a confident public speaker
Pragmatic Innovation is able to help in a number of ways, related to the growth, application and exploitation of technology. Experience which is typical from the last twenty or so years of work amongst PiL and associates include the following –
- Management of IP
- Innovation Strategy, Engines and making the most of your people
- Horizon watching and technology roadmapping
- Organisational behaviour – setting up an ‘Internal Consultancy’
- Developing and cementing alliances
- Gap assessments, technology and management
- Pragmatic Key Performance Indicators (KPI)
We would be delighted to discuss any of these needs with you.
The valuation of a group or organisation must be carried out in a rapid, meticulous and entirely objective way, giving the client clear messages regarding the worth of their potential investment.
This can be a complex task because the target organisation will most likely not know its own worth.
Typical issues encountered are the value of IP and Patents retained – this value is usually inflated but often the value can be underestimated.
In the early days, the client may not wish to reveal its intention so a covert assessment is required.
Overall, due diligence requires persistence and dedication from a group of highly qualified and expert technologists and engineers.
Pragmatic Innovation would be delighted to talk further about any acquisitions or
Approvals, Certificates, Authorisations
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