Services
Pharmaceutical/Medical Product Development Experts
We offer quality assurance, clinical, regulatory, manufacturing and product development services.
Since 2006, J Brooks Consulting, LLC has been providing development services to its clients, including academics and small virtual companies, helping them bridge the gap. We are often asked to find solutions to difficult and unusual problems. We do this while always keeping patient safety our priority. Scroll down to learn more!
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Quality Assurance
Detailed, Flexible, Simple
We create integrated quality systems that add value to your business by minimizing risk and customizing systems to each company's needs.
We offer the following services and systems implementation:
Annual product review
Compliance issues assessment and resolution
Good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP) audits
Deviations, investigations and corrective and preventive actions (CAPA)
Document change control and archive
Document review (GMP, GLP and GCP)
Management review
Manufacturing record review and batch release
Pre-approval inspection preparation
Process change control
Quality agreement development and contract review
Quality control of documents (including regulatory submissions)
Quality systems implementation
Risk management
Training program
Validation oversight
Vendor qualification and management
Warning letter and 483 responses