SERVICES offered by j brooks consulting
With the economic decline, many companies are looking to consultants to fill the staffing gap. Get the most for your money, contact J Brooks Consulting.
J Brooks Consulting offers a wide variety of services. We serve the pharmaceutical, biotechnology, medical device and healthcare industries. 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.
Quality Assurance and Compliance
- Good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP) audits
- Quality agreements and contracts
- Manufacturing record review
- Qualification and validation documentation review
- Review and approval of documents
- Warning letter and 483 response
- System implementation
- SOPs
- Root cause analysis
Regulatory Affairs and Operations
- Regulatory/medical writing
- INDs, CTAs, IMPDs, NDAs, CTDs and eCTDs
- Regulatory strategy development
- Compliance
- Regulatory operations (compilation and production of submissions)
Clinical Research and Development
- Medical writing (clinical protocols, Investigator's Brochures, informed consent forms and study manuals)
- Protocol review
- Site selection
- Clinical site monitoring
- Clinical trial management
- Clinical trial registration
- Case report form design
- Data management
Product Development
- Project management
- Preclinical development
- Manufacturing operations
WHAT PEOPLE ARE SAYING
"rare caliber"
"one of our best go-to resources"
"thoughtful analysis"
"deep knowledge and understanding"
"great to work with"
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