Pricing + Services

Procedure Reviews / Audits

$125/hour — Auditing of policy and procedure documentation for compliance with applicable regulations, industry standards and best practices. Summary report of findings, deficiencies, and recommendations.

SOP Development / Technical Writing

Variable hourly rate — Customized policy and standard operating procedure documents tailored to your existing personnel and processes. Don’t waste your time with “generic” boiler plate documents. Get procedures that are compliant and also accurately reflect what you’re doing.

Master Manufacturing Protocols / Batch Production Records

Variable hourly rate — We work with you to describe and document your manufacturing process, from the bill of materials to final product testing. We can generate product-specific protocols as well as templates for product families that can be quickly adapted as your product line expands.

Electronic Quality Systems Implementation

Variable hourly rate — We can assist you with implementation of electronic systems for document management, training records, batch records, and inventory management using your choice of software tools, or develop cost-effective solutions using tools you may already own.

On-site audits

$150/hour — On site review of policy and procedure documentation, assessment of practice vs. procedure, review of records, interviews with personnel, etc. Summary report of findings, deficiencies, and recommendations.

Product Quality Plans

$150/hour — Process descriptions and risk assessment for each product type. Detailed failure modes and effects analysis (FMEA) with mitigation and assessment methods. Improve product quality and satisfy regulatory agencies.

Regulatory / Licensing Submissions

Variable hourly rate — Preparation of applications and supporting documentation for initial licensing, responses to inspection findings, ongoing renewals and other submissions.

Process Review / Process Optimization

Variable hourly rate — Review and elucidation of current processes using process maps or flow charts. Review of key performance indicators, management review practices, assessment of automation tools, training, and resource allocation.