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Lean FDA Quality Systems and Regulatory Affairs Services

Designed exclusively for startups, small companies and midsized firms or multinational divisions, our work draws upon our career experiences implementing quality systems, balancing budgets ... and defending decisions to inspectors and investors alike.

 

Cost-Effective, Low Maintenance Solutions

• Comprehensive, easy-to-follow SOPs and policies  - GLPs, GMPs, QSRs, records management

• Mock FDA quality systems inspections and gap analyses

• Quality system and Regulatory Affairs program development, implementation, and training

• Process mapping and value stream analyses

• Simple, risk-based supplier quality management and oversight programs

• Streamline FDA regulatory compliance controls and strategies

• Development of risk-based SOPs and policies in line with regulatory requirements, best practices guidance, and business needs

• Specialized corporate workshops on current FDA expectations, Quality by Design, and more

 

Receive

• Compliance with GLP, GMP, and QSR regulations plus ICH, GHTF, GAMP standards

• Adherence to the updated ISO and QSRs

• Personalized, individual attention and expert advice from someone who's walked in your shoes

• One full year of support and advice if you're ever audited or inspected

 

Sample Downloads

• Article Reprint:  Six Pitfalls to Avoid in Supplier Management  (PDF)

• Checklist:  38-Point Lean FDA Compliance Self-Assessment  (PDF)

• Checklist:  Managing the Inspection  (PDF)

• Report:  Ten Ways to Control Compliance Costs  (PDF)

 

More Resources

• Recorded Seminar & Resource Kit:  Bulletproof Yourself against FDA Enforcement

• Recorded Seminar & Resource Kit:  Quality Systems Management Review Best Practices

 

What to Do Next

Contact us today.  We offer a FREE ½ hour consultation to new clients.