A fresh pair of eyes
Claidmhor Pharma Ltd operates as both a technical projects consultant and with organisational development products.
Consulting - technical projects
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Sterile suspension failed to meet specifications and 1+ year's work had not secured root cause. Used process understanding with data driven development and optimisation to define and eliminate/control root causes. Data closely matching to specifications and no failed lots in 6-months follow up.
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Inhaled product which could not be scaled up now made at x200 scale following design of process, experimental design and process optimisation. Filed and approved in EU and US.
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Drug control and processing steps re-engineered and upgraded to meet EU requirements for combination products. Design File submitted and EU Notified Body inspections achieved with successful data bridge and rationale for clinical to upgraded commercial process changes without added clinical work.
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Devices with major foreign particulates contamination complaints from patient/customers' requiring root cause and process, equipment and personnel skills/training improvements to be defined and implemented in moulding and assembly plants.
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Optimised process and methods to improve MDI with poor dose uniformity, failing to meet specification and impacting supply capability. Specifications updated to control uniformity and tool/assembly process changes also made to required timeline. Approval of changes now achieved in over 50 countries.
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Root cause defined and solutions proven for variability in fine particle doses of two drug combinations, manufactured by different companies for APIs, device and product where 2 years' work had not succeeded.
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Developed a new process for viral and prion removal from animal material for biologic products based on regulatory authorities request. Approved in the EU and US and filed in other countries.
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Selected CMO and led transfer of product from original CMO with poor quality/compliance and reliability/delivery for complex combination product through filing/approval in EU and US.
Consulting - organisational development products
Reorganised >120 staff in R&D departments to fewer layers, clarity of responsibilities, with project/portfolio management introduced to drive project implementation, including change programs. Reduced non-project work by >40% by streamlining lab, GMP /QA processes and rationalised lab design and equipment use. Project tracking showed delivery near a much improved target after 6-months.
Improved process by structured monthly review of progress/resource consumption/requirements for four sites in Europe. Resource forecasting tool for people and major plants introduced and refined over 3-months, highlighted bottlenecks in lab and pilot plant with solutions implemented.
Centre of Excellence Set Up with technology transfer from R&D to manufacturing for novel technology. Recruited/training plan aligned with new equipment and facility delivery and first 3 experts recruited.
Device industrialisation plan and 2 key expert roles set up for over 10x increase in scale for device, integrated with product manufacture scale-up. Procurement and risk mitigation plans developed and maintained over prolonged project execution.
Led change program from functional to project organisation across 7 manufacturing sites, for product transfer and industrialisation. Recruited four key Programme Managers and coached multiple Functional managers during the change program.