Services We Offer
Specializing in Regulatory Affairs, Quality Assurance, Clinical Research and
Product Development, 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

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

Recent Projects Include:

  • Performed audits of contract manufacturers to assess suitability and GMP
    compliance
  • Performed investigator site audits to assess GCP compliance
  • Wrote tabular summaries for preclinical section of NDA
  • Wrote clinical quality assurance SOPs
  • Assessed clinical database to determine severity of problems during
    database rescue project
  • Reviewed master and executed batch and packaging records for several
    products
  • Provided analysis of systems and controls necessary to implement specific
    GMP functions in-house in a currently non-GMP facility
  • Audited analytical laboratories for GMP compliance
  • Audited CROs providing data management services for GCP compliance
  • Provided regulatory advice regarding clinical trials
  • Provided quality assurance guidance during manufacturing

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 Health Care Industries
Copyright © 2006-2007 J Brooks Consulting