Cecily Alvarez's Contact Details

Cecily Alvarez's Company Details

J Brooks Consulting

Amesbury, Massachusetts, United States • 17 Employees
Pharmaceuticals

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 ProductionQuality 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 ImplementationClinical Research and Development • Medical Writing • Clinical protocols • Investigator's Brochures • Informed consent forms • Study manuals • Publications • Protocol Review • Site Selection • Monitoring • Case Report Form Design • Data ManagementProject and Operations ManagementTechnical Writing