Cerulean Associates - Lean Compliance, Regulatory Intelligence, and Executive Advisory Services

Since 2006, Cerulean Associates has been helping executives ease compliance costs, speed new drug, biologic or device time to market, lower risks, avoid FDA warning letters, and improve quality systems. The average client saving is 12%.

Every client works directly with our managing director, an international compliance expert and quality systems advisor with two decades of accountability for regulatory compliance and the bottom line, most recently as a C-level executive for a combination biotech and medical device firm.

You receive personalized service, down-to-earth advice and trustworthy information on planning and managing your quality system and compliance programs, saving money, lowering risk, improving effectiveness, and staying ahead of regulators and competitors.

Executive advice and regulatory intelligence newsletter

SmarterCompliance™ newsletter provides timely compliance insights, quality systems advice, regulatory outlooks, analyses of FDA activity, regulatory enforcement, ICH guidance, GHTF guidelines, and Quality by Design recommendations. This monthly newsletter also reports on trends affecting executive liability, new drug, device and biologic development, and quality systems compliance. All in clear, concise language.

Our SmarterCompliance™ executive advisory program compliments the newsletter with additional tools:

• Executive teleconferences and online compliance seminars
• Annual forecast and planning report
• Compliance alerts on new regulatory initiatives
• Bonus downloads and checklists
• Recorded quality management training seminars
• Special industry reports
• Case studies and onsite workshops

Compliance advice and coaching services

Trusted advisory and executive coaching services are available on a private basis with our managing director serving as an expert compliance advisor or quality systems advisor to you and your management team.

Lean compliance and quality by design

Identify cost effective solutions, streamline operations and simplify your compliance burden, saving money and time with individual help from an FDA expert and experienced auditor:

• FDA, EMEA, ICH, and GHTF quality system planning and implementation
• Policy and SOP writing, training and gap analyses
• Quality by Design implementation – from preclinical to post-market
• IT compliance / ICT compliance strategies and assessments
• Revised Part 11 and EU Annex 11 projects and planning
• Supplier due diligence
• Mock FDA audits with detailed recommendations
• Warning letter/483 recovery and response
• Records management program planning and implementation
• Records discovery litigation support
• Pharmaceutical records management expertise

Corporate espionage protection for drug laboratories

Because nine out of ten companies do not have the ability to detect – much less prevent – their intellectual property being stolen by disgruntled employees, contractors, suppliers, and even development partners, we offer our consulting clients decades of experience protecting R&D environments and catching corporate spies. You get help with:

• Intellectual property theft prevention program design and development
• Intellectual property controls assessments
• Corporate espionage awareness training
• Merger and acquisition (M&A) due diligence
• Prospective partner due diligence

We work alongside you, your patent attorneys and your management team to determine the most appropriate controls to protect your intellectual property, trade secrets and newly emerging discoveries from theft.

Clients of our specialized consulting services get the most generous, risk-free guarantee available in the industry: 30-days of free post-project retainer consulting plus one full year (12 months) of free help with any FDA inspection or other audit as you request.