Case Study
Facility Design
CASE STUDY: CLIENT SIZE THERAPEUTIC AREA GEOGRAPHY TIME-LINE DISCOVERY / NONCLINICAL DISCOVERY / NONCLINICAL DISCOVERY / NON-CLINICAL DISCOVERY / NON-CLINICAL DISCOVERY / NON-CLINICAL CLINICAL DEVELOPMENT MARKETING AUTHORIZATION / APPROVAL PRODUCT MAINTENANCE US Delivered intermittently over 12 months (ongoing) CMO to Biotech and Pharma Medium-sized US Company Facility Design CLIENT NEED OUR SOLUTION PHARMALEX VALUE TO CLIENT The team developed a tailored plan outlining the scope of the project to meet the client’s requirements A gap assessment was performed by PLx Ireland on their client’s current Control Strategy for the new facility against the requirements of the EU GMP Guide A number of risk assessments and technical documents were delivered to support individual elements of