FAQ

Lean compliance is a way to simplify and streamline compliance. On average, clients have found it cuts costs and overhead by at least 5% of their total budget each year. By controlling and optimizing regulatory compliance and quality systems, you improve operations, personnel buy-in and business flexibility.

Our clients have also found that a lean compliance strategy improves morale and fosters improved communication and teamwork. For more information and examples, read our lean compliance article from the Journal of GXP Compliance.

As noted in the book, Get to Market Now!, to implement Quality by Design to get the best impact, your teams – development, manufacturing, quality, regulatory, and so on – need to be the same page, to see Quality by Design as a way to navigate regulations to get faster time to market, more flexibility, better medicines and lower costs. One of the first things we'll do is talk with you to explore all the things you hope to achieve implementing Quality by Design.

Typically, we hold a Quality by Design workshop to work through at least one case study and a sample new product you are working on. The goals is to ensure your management team "gets it" and has an overall consensus to go forward. At that point, it's time to pull together a cross-functional project team to plan and then implement the overall project.

Finally, rather than outsourcing, experience has shown it is best to rely upon your people to do some of the "heavy lifting" to implement Quality by Design. This is the only way to make sure the knowledge is transferred and Quality by Design is appropriately adapted to your organization.

We can, but we'd prefer to help you get a bigger bang for your dollar, so when it comes to IT or computer compliance, we prefer to focus on: policy creation (or revision) and training, Part 11 / Annex 11 auditing, long-term information integrity, and cost-effective, risk-based validation strategies.

Several clients have turned this around and used our expertise to help them respond to and recover from regulatory inspections that cited poor IT controls and records management issues. You can learn more about our cost-conscious approach to IT compliance with our Part 11 / Annex 11 self-assessment.

Senior management in small to medium-sized companies, and divisional executives in large enterprises. In general, we focus on those firms regulated by the US Food & Drug Administration (FDA), but several of our clients have been service suppliers to companies that are regulated by the FDA. If you sign a mutual non-disclosure (confidentiality) agreement with us, we can provide you a complete list of specific clients and reference contacts.

Co-founder, managing director and principal consultant John Avellanet opened the doors of Cerulean Associates LLC in April 2006 after more than 15 years as an executive accountable for regulatory compliance, quality systems, new product commercialization, IT, records management and trade secret theft prevention. The company's principal office is located in Williamsburg, Virginia.

Our clients repeatedly cite six main reasons why they chose Cerulean: practical approaches, flexible pricing, real-world "walked-in-those-shoes" experiences, high integrity, strong references from previous clients, and the individual, personal help from Cerulean's managing director (e.g., we don't sell you with senior people, and then have junior consultants do the work).

Of course, that's all in addition to the guarantees, free post-project support and our exclusive 12-month audit warranty.

And, because we rely upon positive word-of-mouth and referrals from clients for new business, we have every reason to do the best job possible for you.

Be aware that Cerulean prefers to work with what you have, and enhance and strengthen it rather than recommending major overhauls or complete outsourcing. If this is a sticking point for you, take a look at the ten important reasons not to hire us.

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Yes - take us up on our offer of a free initial phone or email consultation, even if it's just for a second opinion.

This site should also be providing you some idea of what it's like to work with us and why many of our clients see Cerulean as a safe choice. You might want to read through our various articles as they relate to your areas of concern (see the article section in our resource library). We've also written a well-received, non-promotional article published in BioPharm International on how to choose a consultant.

You may also want to subscribe to our newsletter for one year and see if the tips and strategies are of value to you - there is a no-risk, money-back guarantee with SmarterCompliance. And, of course, you can purchase any of our FDA conference reports, industry best practice workbooks or pre-recorded webinars (they come with reference materials).

Yes. Unlike many consultancies, Cerulean offers a money-back guarantee, plus 30 days of free retainer-based consulting after our work together is complete. We post the Cerulean guarantee online, and include it in the terms and conditions of any proposal or statement of work we provide.

We also give our consulting clients an exclusive twelve months of retainer expertise to handle any audit or inspection - free of charge.

We schedule multiple check-ins with you during any project to proactively improve our work and productivity together. Cerulean is a member of the local Virginia Better Business Bureau, and several other industry associations that require strict adherence to published codes of ethics (these are listed in the Cerulean guarantee).

We post our pricing levels and are constantly calibrating it to ensure we offer the best return on investment to our clients. We offer options for every budget as long as you are willing to be flexible in how the objectives are achieved.

Because we keep our overhead low, our costs are generally lower than many other consulting firms. We also offer significant discounts if you have been referred to us.

As part of our negotiations with you, we work to figure out - in dollars and cents - what the outcome of any potential work together is worth. To help start the conversation, we can present a sample "dollarized" list of outcomes (such as "writing and training 8 SOPs") with dollar values based on typical industry costs and research. We then provide you the cost of Cerulean to conduct that service and deliverable. This allows you to easily compare the cost of Cerulean to other options. And this lays out the facts that clearly demonstrate the positive return on your investment in Cerulean's services.

First, we discuss the outcomes you'd like to see - both the tangible (such as training on ICH Q8 and Quality by Design principles) and the intangible (for instance, obtaining buy-in from the rest of your team and management colleagues to adopt Quality by Design in preclinical).

Then we draft a proposed agenda and review that with you. For most workshops, we prefer to have a mix of presentation, case study example, and then a real-world exercise working through one of the issues you face so you can start to apply your new knowledge immediately.

Depending on your needs and desired outcomes, workshops can be half-days, full days or even two days. See our Workshops and Training section of the consulting services for more information.

Depending on the specifics (putting in place a quality system or records management program, or revising inflexible IT policies or incorporating ICH guidelines into an FDA compliance program), we first have a "walk-through" of your business, operations and current policies or existing SOPs.

We then craft a draft strategy, a prioritized plan and timeline, and a set of visuals and diagrams to illustrate the end situation. We then sit and discuss these preliminary drafts with you. Together, we agree on revisions and schedule regular check-ins. As the project moves along, we keep you as informed and as involved as you want.

With most of our clients that hire us for a long-term project, we suggest breaking it apart into incremental phases from which they can walk away at any point. This helps reduce their risk and ensure they get results fast.

At the end of the project, we conduct a closeout meeting with you to ensure you satisfaction with all the deliverables and results, and then schedule a thirty day post-project check-in to ensure your continuing satisfaction and answer any further questions that might have arisen since our work together ended.

After our initial discussion together (either over the phone or in person), we work up a simple "situation review" that summarizes what was discussed. We then provide you our six-step pre-commitment process and our mutual non-disclosure agreement (e.g., confidentiality agreement or NDA). There is no point in going further if you are not willing to invest the time in signing an NDA, either ours or yours.

Once the NDA has been signed, we hold a "needs analysis" meeting with you to understand in more detail your objectives and concerns, pencil in a preliminary goals and identify measures of success.

We send you a draft proposal that spells out your situation, your needs, your objectives, the value to you of the objectives, and several options for how to accomplish those objectives. Together, we review that for accuracy. Once you are satisfied that we understand what you want to achieve, then we discuss cost options.

All along the way, you have many chances to say "no" and disengage.

All of our clients receive a free subscription to our monthly newsletter of compliance tips and strategies, SmarterCompliance. We also offer retainer-based contracts, and keep all of our former clients informed of new service offerings, webinars, speeches, industry reports and other recent publications.

With every client, we like to establish a good relationship so you come to see us as a trusted advisor...even if we only worked together for a one day workshop.

Cerulean is primarily a one-person company, run by the managing director and principal consultant, John Avellanet. There is one silent partner who serves as the editor of our monthly client newsletter, SmarterCompliance. Our "associates" are independent experts in their field with whom we've worked and trust. Some of them you can see in our adjunct section.

If you decide such additional expertise is necessary, we will either refer you to them directly or sub-contract with them on your behalf as you prefer.

Suh · roo · lee · uhn. Like the color blue in a box of crayons. Our managing director's last name, Avellanet, is pronounced similar to "have-a-bonnet."

When you begin to perceive an opportunity or a threat is the best time to reach out for independent advice; the worst time is when the crisis has hit and you are forced to react. People do not make good decisions when forced to choose between what few options remain.

Once you perceive something new coming down the pike toward you that may be a threat or an opportunity, consider contacting a consultant with expertise in that arena to ask them to help you assess risk, evaluate the opportunities and envision better alternatives. If you like working with the consultant, then consider asking them to help you build consensus within your organization to tackle the new opportunity or threat (several of our clients have asked us to conduct corporate workshops for the sole purpose of motivating a discussion and building consensus in their companies to adopt Quality by Design).

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If that sounds reasonable to you, then please email our managing director to set up an initial phone discussion.

In part, you have to decide if choosing a consulting firm should be based on brand and big advertising budgets (which you will be helping pay for), or selected for its expertise, flexibility and ability to reduce your risk (e.g., such as through warranties and post-project support).

You also need to ask yourself if your rationale for selecting a consultant is akin to the old, "no one ever got in trouble hiring IBM," or if you want to select a consultant who regularly deals with FDA officials and industry experts, as opposed to a firm where the CEO and other senior consultant haven't spoken with someone in the FDA or any other agency in years.

Cerulean is smaller and more personal. Because of this, we charge less so you can save money while getting individual attention, a flexibility and a set of industry-unique consulting guarantees.

One thing to consider as well is size and number of clients. Because Cerulean only handles a select number of clients per year, our clients don't worry about new project managers or subcontractors suddenly showing up, paying for on-the-job training of new consultants still wet behind the ears, and so on.

You hire us, you get us. And because we depend on word-of-mouth referrals and recommendations, we have every incentive to do the best job possible.

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This is a common, and often valid, complaint about consultants. Our goal is to give you enough knowledge and expertise to be able to solve future issues yourself.

So, if we notice other areas that might need shoring up that are outside of our original scope, we will mention it, but unless it directly impacts our work together, we will only offer suggestions for you to consider in the future - including suggestions that do not involve us.

If you are considering our services, please first read our 10 Important Reasons NOT to Hire Cerulean. And consider taking advantage of our no-obligation offer of a free email or phone consultation - even if it's just to get a second opinion - it's a great way to get a real feel for what it would be like to work with us.