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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!

If you don't see something here, just ask! 

Services: Services

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

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