J Brooks Consulting is a consulting firm specializing in all aspects of medical product development. We provide regulatory, quality assurance, clinical research, data management, preclinical, product development and manufacturing support to pharmaceutical, biotechnology, medical device and health care companies. Clients often turn to J Brooks Consulting for assistance with difficult and/or unusual compliance or quality problems. Most of our clients are small pharmaceutical companies or academic centers. Services include: Regulatory Affairs and Operations (INDs, NDAs, 510Ks, CTAs, IMPDs, MAAs, DMFs) Writing Strategy Compilation and Production Quality Assurance Audits GMP manufacturers, processers and packaging and labeling vendors GLP laboratories: in vitro, in vivo, analytical and bioanalytical GCP including: clinical sites, phase I units, CROs, data management, statistics, clinical laboratories, bioanalytical laboratories and pharmacies Document Development and Review System Implementation Clinical Research and Development Medical Writing Clinical protocols Investigators Brochures Informed consent forms Study manuals Publications Protocol Review Site Selection Monitoring Case Report Form Design Data Management Project and Operations Management Technical Writing