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 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