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.
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.
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.
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.
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:
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:
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:
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.
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.
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!
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.
- NO Billable Hours
- NO Pass Through Expenses
- NO Change Orders
- NO Missed Deadlines
- NO Product Go Live Dates Missed
- NO Audit Observations