Chapman Pharmaceutical Consulting, Inc. Chris Chapman, MD
Chapman Pharmaceutical Consulting, Inc. Chris Chapman, MD 

What We Do

Product Development

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.

 

Pharmacovigilance

Dr Chapman is an international pharmacovigilance software/database expert in these databases:

ARGUS – Oracle Health Sciences Argus, data mining for serious adverse

              events

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

                event coding

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.

Chris Chapman, MD

Founder and CEO

Chapman Pharmaceutical Consulting, Inc

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