PDS offers a full contractor management programme, ensuring smooth progress.
PDS assists companies that are placing work at CROs for pharmaceutical development from early stage development to phase three and beyond. This involves CRO search and selection and includes analytical method development, compliance audits, clinical trial material manufacturing, packaging and labelling, quality management and QP release for clinical trials, technology transfer, new product introduction, and project management.
PDS has contracted entire chemistry, pharmacy and analytical programmes for the flovatriptan NDA. Contractors for chemical, analytical and pharmaceutical development were identified, evaluated and selected for a portfolio of six compounds. One major project involved relocating the manufacturing from one site to another for a multi-national pharmaceutical company.
PDS prepares a short-list of contractors with the requisite skills, reviews their facilities to ensure competence and prepares costings based on accurately-defined requirements. PDS commissions and manages contractors through every step of the process.
PDS offers in-house training in CRO selection and management including recommending SOPs, as well as systems to be put in place to limit the liabilities to ensure value for money.