simple compliance

BIGGSB WILL CHANGE YOUR PERSPECTIVE ON HOW REGULATORY COMPLIANCE COMPANIES CAN (AND SHOULD) OPERATE.

BiggsB is the most comfortable, easy to use regulatory compliance and implementation company available. Here at BiggsB, we understand the layers that need to be translated to all stake holders – even those in unrelated business units.

We handle your concerns with care, and the workload with ease.

This has been the foundation of our business for 15+ years. Our clients range from the largest global corporations to small startups. They are players in the fields of biotechnology, pharmaceuticals, medical devices, contract laboratories, contract research organizations, and equipment and software vendors. Our clients are diverse, but they all come to us with the same question:

“What do the regulations mean specifically for me and my company?”

That’s where BiggsB steps into the picture.

We lower your compliance costs.

Through experienced implementation BiggsB will not only lower the cost of your compliance but often lowers other costs of doing business. Compliance should add value through intelligent adjustments to your business practice. When done right, this can be accomplished in subtle, non-invasive ways.

And best of all, no more bureaucratic headaches.

BiggsB is a conversational intuitive human experience turning what can often be a drudgery into an enjoyable human exchange. We are true experts that also have social skills and a casual demeanor. We will create elementary implementation no matter the complexity of your processes.

CONTINUE TO CASE STUDY ➤

We don’t want to bore you with too many case studies that tell you how we overcame insurmountable odds. Blah, blah, blah. We’re tired of those too. Instead, here is one example of some stuff we think is pretty cool. If you want more details, we’ll be happy to oblige.

The One-Two Punch

This is the one our team simply refers to as “That Project”. It’s the one that made us wake up in the middle of the night sweating. It’s the one that, at times, made us not sleep at all. It’s also the one that helped make us what we are today. The best in the business. This is how it went down:

The First Hit:

“Global Compliance Management”

We were initially hired by a major international healthcare company to manage their global compliance from a site location in Northern California. Our challenge was to implement and support their compliance systems as they continued to grow. We were helping to create a large site location with a strong infrastructure. No sweat. We live for this kind of project. Large. Comprehensive. Challenging.

Our team succeeded in delivering:

- Global compliance management for one of the biggest companies in the business.

- Managing 32 projects over the course of five years.

- Successfully delivering nine global, top-priority projects over the course of five years.

- Integrating our team of twelve with existing and new employees as the site grew.

- Creating a harmonious work environment for in-house employees and consultants.

The Second Hit:

“Site Closure Under Extreme Pressure”

Everything was flowing smoothly until chaos struck. In our fifth year on-site, our client purchased another major healthcare company. However, nobody was aware of this until the local news stations aired it publicly. And that’s how company employee’s at our site found out. As you can imagine, it created a work environment with many fires to put out. On the best day, what we do is challenging. Now add uncertainty and upset employees worrying about job security. We braced ourselves for what was coming.

The last-minute word from our client was to close the site for relocation. This was massive. We were required to finalize all projects, plan for closure, analyze resource risks, develop timelines and budgets, meet with executives, develop processes for closure, connect with our teams, fight political battles, and make it happen. We did it.

Our accomplishment included:

- Decommissioning or transfer of 44GxP systems (stand-alone and client server).

- Reviewing and assessing 50 years of data.

- Determining which data to keep, which data to move, and which data to delete.

- Communicating plans with 2,500 employees on-site and staying on track.

- Closing site under intense deadline pressure.

- Locking the door on the way out

See how we do it

KNOWLEDGE

We have 15+ years in this industry. Everything mentioned on this page rides on our knowledge of this industry. We know systems. We know quality processes. We know system validation. We know regulations. We know GLP. We know GMP. We know HIPAA. Our knowledge makes everything else possible.

COMMUNICATION

This is the foundation of any successful relationship in business or life. We want to hear about your needs and concerns. That’s how we develop strategy. In order to make that happen, we need an open dialogue. This can involve actual conversation, written word, or visual presentation. We customize it to fit the client.

COMPLIANCE

It’s a simple word. But it means many things to us. Knowledge. Experience. Implementation. Change. Rules. This little word can strike fear in the hearts of our clients. But it puts a smile on our faces. We know compliance so intimately that we don’t feel constrained by its boundaries. We’re so comfortable with compliance that we’re left with room to think outside of the box. It allows us to focus on what will work for each of our clients on an individual basis.

MANAGEMENT OF PROJECTS

Big. Little. Global. Local. Simple. Messy. It doesn’t matter. No missed milestones. No excuses. No blame. We get it done. That’s what we do.

STRATEGY

Think. Act. Do. It’s impossible to reach a goal without a strategy. This means mapping out our client’s interests, objectives, and outside influences. We create a road map to the finish line and we pinpoint and eradicate any threats along the way. Our strategy hero is Miyamoto Musashi.

MANAGEMENT OF PEOPLE

Take a look up towards the top of this page. It’s that “communication” word again. It sounds easy, right? It’s not nearly as simple as it seems. Trust us on this. In order to manage people, you must manage personalities. We don’t expect you to change for us. We adapt our approach based on the way you and your employees function. And believe us when we say we’ve seen it all.

INFORMATICS

This is where we live and breathe. It is located at the intersection of information science, computer science, and health care. We make these three things interact seamlessly. It is the foundation that holds together each and every client. We make it rock solid.

Our experience includes

Project management.

Portfolio management.

Development and implementation of quality systems.

Computer system validation.

Total IT compliance solutions.

Laboratory equipment qualification.

Commissioning and qualification of new or existing facilities.

Vendor/supplier audits in FDA, CLIA, Sarbanes-Oxley and HIPAA-regulated environments.

Each member of the BiggsB team has a minimum of 10 years of experience in compliance, regulatory, and project management experience. And we recognize that true leadership comes not only from knowledge of the industry, but from the ability to manage people and develop a customized plan of action for every project.

The BiggsB teams provide integrated services; from project conception through planning and into project approval and implementation. We not only assist in completion of the entire project life cycle, but also identify and recommend alternative solutions which save our clients money in the long run.

THINK. ACT. DO. ™

These three words embody the BiggsB philosophy, which stems from 10+ years of battling fierce politics, fast deadlines and ever-changing compliance standards. It’s the approach we use for all of our projects and it drives our methods, strategies and communication. And it just plain makes good sense. A well-planned strategy needs to be developed before it can be executed.

And it doesn’t just work for the PMP. It’s the formula for success in any environment.

AgileCSV ™

We call this “the game changer”. It was developed as the solution to an industry-wide issue. Why do computer systems validation (CSV) projects only deliver 25% on time? Why are they managed so poorly? Why do they cost so much?

AgileCSV™ combines the best of the agile iterative software development process with the traditional waterfall CSV process and delivers a world-changing, game-changing, earth-shattering end result. Accurate. Better. Faster. Cheaper. It’s our little secret weapon. This is our approach to compliance, CSV, qualification, production, facilities, GMP manufacturing, GLP production, studies, trials, CLIA, lab process, HIPAA, and health protection. We combine the main elements of informatics and compliance to focus on people, computerized system, processes, and data.

Enough reading, let's talk!

DEMYSTIFYING THE WORLD OF REGULATORY COMPLIANCE

Let’s face it. Nobody likes to deal with wading through the muck of regulations. It’s time-consuming, confusing, and changing constantly. In a nutshell, BiggsB is all about partnering with clients to demystify the field of regulatory compliance, providing expertise and software solutions to do the job.

ABOUT

The BiggsB Team provides comprehensive compliance and project management solutions for today’s rapidly evolving Life Sciences companies.

As you can see below, our client list ranges from the largest multinational corporations to small startups in Biotechnology, Pharmaceutical, Medical Device, Contract Laboratories, Contract Research Organizations, and Equipment & Software vendors. They are players in the fields of biotechnology, pharmaceuticals, medical devices, contract laboratories, contract research organizations, and equipment and software vendors.

Our clients are diverse, but they all come to us with the same question. What do the regulations mean specifically for me and my company? That’s where BiggsB steps into the picture.

BiggsB is a Results Only Work Environment (ROWE) company, focusing on delivering products and solutions (Results) and not billable hours.

We have found that the single biggest advantage to our clients was eliminating the age old “billable hour”. Nothing has hampered creativity and induced waste in our industry (both in terms of financial cost and delay of product delivery) more than the “billable hour”, so – we don’t do it!

our clients

Who is home in the house of Bluegrass?

Bluegrass is the guy behind the BiggsB name. Yes, Bluegrass is actually his real name. He’s a builder. He’s a risk-taker. He remains calm in the face of pressure and deadlines. And if you ask anyone, they’ll tell you he’s a nice guy who came from humble beginnings and hustled his way into this business.

Some tidbits of info about Bluegrass:

- The first company he built was atomic american productions.

- His BiggsB racing company and team has won the longest endurance race in the country.

- He values creativity as any teams #1 goal.

- He likes to get dirty, get involve in projects, and interfaces with every client.

- He believes in autonomy in the work environment, letting people do what they do best in the way they do it best.

- He believes in being accessible, sharing and helping if and when he can.

- He still believes he can change the world, impact people, improve business.

Want to know more about Bluegrass?

He’ll be happy to tell you more.

THE WAY of BIGGSB

- NO Billable Hours

- NO Pass Through Expenses

- NO Change Orders

- NO Missed Deadlines

- NO Product Go Live Dates Missed

- NO Audit Observations

get in touch

contact details

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+1 +1 650-204-1869

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