We provide expert medical consultation on the development and management of domestic and global product development programs for biotech, pharmaceutical, and medical device products.
Product Life Cycle
We cover all aspects of product life cycle development including scientific, medical, clinical, regulatory, toxicology, manufacturing, patent review, and market assessment.
Expert, Experienced Consulting Services
Our consulting services include: strategic planning, protocol design, project management, clinical trial management, medical safety management, regulatory affairs support, preparation for FDA Advisory Panel meetings, data analysis and report preparation, chemistry and manufacturing controls, quality systems management including GCP/GLP/QSR/GMP audits, document management and preparation, design control planning, process validation and corrective and preventive action, and safety reporting for serious adverse events and Medical Device Reports.
Dr Chapman is an international pharmacovigilance software/database expert in these databases:
ARGUS – Oracle Health Sciences Argus, data mining for serious adverse
Empirica – Oracle Health Sciences Empirica Signal, data mining for product safety signals
TrackWise – Sparta Systems EQMS Patient Compliance and Complaints
MedDRA – Medical Dictionary for Regulatory Activities, medical adverse
VigiBase – Upsala Monitoring Centre and World Health Organization (WHO)
global safer use database
FAERS – US FDA adverse Event Reporting System
click on images below for database websites.