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Client Results

Do your consultants give you twelve free months of support for any audits or inspections?

We do.  Check out what our clients say about us.

 

Your Goal		Our Solutions
Revise our regulatory affairs program to be cost-efficient and proactive		Following an on-site mock FDA audit and gap analysis, made a series of short-term and long-term recommendations that would improve compliance while lowering costs and boosting productivity.  Then worked with client to revise and write policies, internal guidelines, and SOPs.  The result was a savings of $400,000 in resource workload and, as an added bonus, the prevention of an FDA warning letter after agency reviewers saw the results of our work.
Help us put in place an FDA-compliant records retention program we can live with		Over the course of four months, after providing a number of different options based on budget impact and long-term headcount to maintain, designed a records retention and management set of policies and rules for small pharmaceutical client.  Included records auditing and control procedures, plus quality amendment contract clauses that firm used to oversee and maintain critical suppliers and outsourced functions (CMOs) to ensure suppliers AND client were ready for FDA and EMA inspections.
Rescue us from FDA inspection findings		In 3 months, put in place new compliance framework to address all FDA issues - and then some -that also dovetailed with and strengthened what CRO client already had in place.  As a result, client landed two new multi-million dollar projects and restored their good name.
Put in place an inexpensive FDA quality system		Designed, drafted, and implemented an FDA and GHTF-compliant quality system for a startup medical device firm for less than $40,000 (USD) over a 6-month period.  Firm was able to immediately expand sales into Canada and Mexico, putting them four months ahead of their initial strategic plan
Get new products to market faster		Shaved 16 months off the development timeline of a combination product by redesigning the roles of IT and marketing, implementing rapid-prototyping technology and designing an information management "book-shelving" strategy.
		For the product development division of a Fortune 1000 company, remapped and streamlined their processes, increasing their efficiency by 12% and reducing risks with automation.
Eliminate the  frustrations and costs of computer validation		Saved our client $0.26 million (USD) in four months.  How?  We worked with the client's management team to give them the know-how and the confidence to determine the right level of IT compliance for their business.
		Our risk-based Qualification-in-a-Box™  methodology helped a medical device design organization reduce validation time and effort to the FDA's 21 CFR Part 11 standards.  For spreadsheets alone, the validation effort was reduced from 30 to 10 "man-days".
		Redesigned a more flexible change management process by tailoring the experiences of global firms to our local client. The resulting freed resources were then shifted to help complete other internal company projects.
Help us get ISO-certified		Modified our detailed mock FDA audit to serve the ISO need, presenting a lab services company with a step-by-step improvement plan and strategy for closing their gaps and getting certified to both ISO and NIST standards within 8 months - without using any outside expertise beyond our initial audit and report.
Make the audit process faster, easier and with fewer findings		Aligned technology controls, plans and organizational accountabilities with business and compliance expectations.  10 months later, the company saw audit findings reduced from 16 to 1.5.
		In a DEA-certified laboratory facility, implemented a business-process focused chemical and formulations tracking and inventory system to resolve communication and coordination issues with IT, laboratory managers and safety officers.
Bullet-proof our IT or Compliance projects		For a Fortune 100 company, rescued a project running four months behind and $.5 million (USD) over budget by overseeing three vendors and their project teams.  Within 90 days, the project was 22 days ahead of schedule and under budget.  The improved project customer satisfaction provided our client with two key value-adds:  the opportunity to implement additional "nice-to-have" project components during the "recovered" days and then, on a more personal level, a promotion.
Lower my operational costs		For an engineering group, designed a proactive system maintenance plan and a "compliance health check" program that increased the usability of high-end graphical modeling systems from four to six years, allowing two years of funding (that would have been spent on new computers) to shift to other company projects.
		On behalf of a lab director, negotiated long-term maintenance contracts and services with the lab's vendors that decreased costs by $200,000 (USD) over five years.
Improve our business value and service		Facilitated creation of a continuous improvement framework for IT that saw business satisfaction rise from 6.1 to 9.7 (out of 10) within twelve months.  The business received better service and IT received more funding and freedom.

 

 

Are You Ready to Turn Compliance into Competitive Advantage?

With Cerulean, you get long-term benefits and bottom line results.  We guarantee our services, period.  Our clients get 12 months of free inspection support and monthly compliance advice.

 

Still Skeptical?

Read what our clients say or learn about the exclusive FDA business coaching and advisory program for executives and business owners, the SmarterCompliance Toolkit.

Isn't it about time you got more than SOPs from your compliance program?