Claidmhor Pharma consultants and associates bring more than 100 years' experience with biotechnology and pharma companies. To benefit from this wealth of knowledge call us in Cheshire, UK on:
Gap Analysis for modified release formulation acquired by client with solutions/plan and review “gates”. Also led gate reviews through to filing.
Device technology review and testing plan with optimal animal PK model and studies to prove equivalence for current complex peptide product. Ph III studies now underway on strength of data.
Peptide API and product development, manufacturing, clinical supply plans for Ph III and commercial supply developed. Identified areas for added work, with scope and budget estimates. Client acquired product and Ph III completed.
Technology review for specific drug delivery technology. Developed feasibility proposal and comparative timelines and costs including licensing terms for top three companies’ technology. Client now progressing with selected partner in Ph III studies.
Internal review for Board of start-up company approaching first clinical studies. Developed gap analysis and plan with resources, costs and QA requirements to meet requirements for Ph I – Ph III programs.
Device review prior to EU CE mark filing to identify gaps/solutions in filing, manufacturing and test process and readiness for site inspection. Implemented these for product now with approved CE mark.
Patented SR peptide injection developed using CRO labs directed by Claidmhor, giving optimised pharmacokinetic profile and injectability. Ph II and III supplied for global studies.
Plan agreed with EU/US authorities to bridge from Ph I/II formulation to Ph III/commercial device without delay or added clinical studies by design and testing program for device/formulation and strong CMC and animal PK support. Ph III studies underway.
Optimised Plan for Process Validation for peptide, product and device from three CMOs. Completed with minimised amount of peptide and flexible batch sizes. Completed with successful FDA PAI, and for >2.5M$ less than CMOs proposed and avoided major stock expiry write off.
Improved process by structured monthly review of progress/resource consumption/requirements for four sites in Europe. Resource forecasting tool for people and major plant introduced and refined over 3 months, highlighted bottlenecks in lab and pilot plant with solutions implemented.
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.
Interim Project Director for major compliance improvement program on manufacturing and development site, and achieved successful FDA PAI and MHRA inspections.