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Consulting Services


Curious if Cerulean is right for you?

Try our risk-free
Small Business Audit Protection Package

Get long-term results with a triple guarantee.

 

Project Assurance | Workshops | Virtual CIO | Prevent IP Theft | Quality by Design | Lean Compliance | Interim RA/QA

Lean Compliance

Reduce costs and overhead, improve quality, strengthen compliance, and better your business flexibility.

Design and implement a cost-effective, flexible compliance program for regulations or records management.

Focus is on process simplification, increased flexibility, practical controls, better information management and integrity, plus long-term options and triggers for further simplification.		   Who Benefits?
Businesses that have to deal with FDA, ICH, HIPAA, ISO, electronic discovery, or records management compliance.
We prefer to use a fixed fee for all compliance activities.

 

Lean Quality by Design & PAT

Cover your new product development bases to ensure success and rapid FDA approval:   Who Benefits?
  • Innovation
  • Regulatory compliance
  • Quality systems
  • Data integrity for submissions
  • Intellectual property security

Get your new products to market faster, easier, for less.

 FDA-regulated businesses that need faster time to market, less risk and lower development costs for their new products and R&D efforts.
We prefer to use a fixed fee for all compliance projects.

 

Prevent Intellectual Property Theft

Protect your new R&D discoveries from:   Who Benefits?
  • Outsourced R&D staff with hidden agendas
  • Contractor and vendor "fishing expeditions"
  • Employees who can't keep a secret
  • Development partners who "borrow" ideas too liberally
 Businesses who outsource their R&D and new product development; executives worried about IP theft before trademarks and patents are granted.

Techniques can be "reversed" to serve as due diligence audits of potential partners.
We use a fixed fee incorporating travel expenses as necessary.

 

Interim Regulatory Affairs / Quality Management

You concentrate on growing your business while we handle:   Who Benefits?
  • SOP writing
  • Policy writing
  • Training
  • Due diligence and mock FDA audits
  • Technical agreements reviews
  • Compliance/quality project management
  • Transfer knowledge and expertise
  • Help hire and screen a full-time replacement
 Designed exclusively for start-ups and small firms with less than $500M in revenue or venture capital.

Only 2 participants per month.
The program is available by calendar month with fixed-fee pricing; discounts for quarterly sign-up.

 

Virtual CIO & Records Expert

Concentrate on your business, not your computers.  Cerulean will:   Who Benefits?
  • Develop a 3-year IT and long-term data integrity strategy
  • Identify technologies and controls to improve productivity
  • Streamline your systems and processes
  • Recommend IT projects, records storage and review outsource vendors
  • Craft technology and records policies and train staff
  • Oversee projects with your staff and vendors
 Organizations with $900M or less in revenue (including nonprofits) who need technology management and records expertise at far less cost than a full-time executive.

Limited to 6 organizations per calendar year.
We use a fixed-price in 90 day increments.

 

Project Assurance

We work closely with you to make sure that you succeed - from project planning and delivery, to turnaround and rescue - you get experience and expertise on your side.

   Who Benefits?
Organizations or executives who need world-class results from their IT, compliance and quality projects.
As soon as you pick up the phone, you have 46+ years of hard-won experience and accountability working for you. We prefer to use a fixed-price in 90 day increments for this service.

 

On-Site Corporate Workshops

Packed with practical information, detailed examples, case studies and hands-on exercises.  Each attendee receives reference handouts, article reprints and more.

You may also be interested in our recorded webinars and toolkits.

   Who Benefits?
Businesses who want to apply industry best practices today.

For up to 25 participants.
Following the session, you receive up to a full-day of on-site consulting for free. If you're interested in a speaker for your event, see our public speaking page.

 

Other Consulting Services

Let us know how we can help you overcome your frustrations.  We can: Who Benefits?
  • Train and coach senior management in compliance, quality or IT concepts
  • Implement e-discovery and records management programs
  • Layout and train staff on a "deemed export" compliance strategy
  • FDA conference summary reports with tailored recommendations
  • Provide expert witness testimony
 Work toward your goals, whether your budget is $500 or $50,000.
See our pricing section for standard rates; fixed price proposals are available.

Wondering if we're right for you?  Try our Small Business Audit Protection Service today.

 

Call +1.757.645.2864 to schedule your free initial consultation.  There is no obligation or cost involved.