Services Offered
J Brooks Consulting offers a wide variety of services including the following:

Regulatory Affairs
  • Regulatory/medical writing
  • IND, NDA, CTD and IMPD submissions
  • Regulatory strategy development
  • Compliance
  • Regulatory operations

Quality Assurance
  • GMP, GLP and GCP audits
  • Review of contracts and quality agreements
  • Batch record review
  • Document review and approval
  • Warning Letter/483 response
  • System implementation
  • SOP writing

Clinical Research
  • Medical writing
  • Clinical site monitoring
  • Clinical trial management
  • Clinical trial registration

Product Development
  • Development strategy (pre-IND to post-marketing)
  • Regulatory options and considerations
  • Project management
  • Operations

J Brooks Consulting is affiliated with other consultants and service providers who
provide these and other services.  Please contact J Brooks Consulting for more
information about the services provided.  
Serving the Pharmaceutical, Biotechnology,
Medical Device and Healthcare Industries
Copyright © 2006-2011 J Brooks Consulting