Prespectives Llc

FDA/GXP Risk and Knowledge Management Services founded by former FDA Pharmaceutical Quality Program Expert/ FDA/ORA-Certified BIMO Investigator. Services Include: FDA Inspections Hosting GXP Inspections GLP and GCP FDA inspection readiness training Mock GLP and GCP Inspections Mock FDA Form 483 and response Mock Establishment Inspections Reports TRAINING (all from Beginners to Experts) General GCP (21 CFR and R6) GXP Root cause analysis and CAPA New Clinical Investigator Responsibilities AUDITS Routine and for-cause: venders, clinical sites, control laboratories WRITING Clinical Protocol, Clinical Study Reports, Investigator Brochure, eCTD all modules Standard Operating Procedures/Policies