J Brooks Consulting

J Brooks Consulting is a consulting firm specializing in all aspects of medical product development. We provide quality, regulatory, clinical, 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. Our clients range from small start-up companies to academic centers to large corporations. Services include: Quality • Overall global quality management • Quality systems implementation and management • Policy and SOP development • System implementation and validation • Audits o GMP: drug substance, drug product (including Annex 1), packaging and labeling, analytical, stability, etc. o GCP: clinical sites, Phase 1 units, CROs (including GDPR), data management and statistics, clinical laboratories, bioanalytical laboratories, pharmacies, etc. o GLP: safety pharmacology, toxicology, genetic toxicology, analytical, bioanalytical, etc. • Document review • Batch record review and batch release • Coordination with Qualified Person Regulatory Affairs and Operations • Technical writing and compilation • INDs/IMPDs/CTAs • 510Ks • Marketing application support • DMFs Clinical Research and Development • Medical Writing o Clinical protocols o Investigator’s Brochures o Informed consent forms o Study manuals o Publications o Protocol Review o Site Selection o Monitoring o Case Report Form Design o Data Management • Project and Operations Management • Technical Writing