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. We understand the layers that must be translated to all stakeholders—including those in unrelated business units

WE HANDLE YOUR CONCERNS WITH CARE AND THE WORKLOAD WITH EASE.

That’s been our foundation for over 20 years. Our clients range from the largest global corporations to small startups in biotechnology, pharmaceuticals, medical devices, contract labs, CROs, and software vendors


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

That’s where we step in.

We lower your compliance costs.

Through experienced implementation, BiggsB not only lowers the cost of compliance -we often reduce your overall business costs. Done right, compliance should add value through smart, subtle, and non-invasive adjustments to how you operate.

AND BEST OF ALL: NO MORE BUREAUCRATIC HEADACHES.

BiggsB brings a conversational, intuitive, human approach to what is too often a painful experience. We’re true experts with social skills. No matter how complex your processes, we make implementation feel simple.

WE’RE NOT GOING TO BORE YOU
with endless case studies about overcoming insurmountable odds.
Blah, blah, blah... We’re tired of those too.

Instead, here’s one example we think is actually cool.

THE ONE-TWO PUNCH


The First Hit:

“Global Compliance Management”


We were brought in by a major international healthcare company to manage global compliance from a site in Northern California. The job: build infrastructure, implement systems, and support growth.


  • Global compliance management for one of the biggest players in the industry.
  • 32 managed projects over five years.
  • Nine top-priority projects delivered globally.
  • Seamless team integration across 12 consultants and in-house staff.
  • A harmonious work environment through rapid growth.

The Second Hit:

“Site Closure Under Extreme Pressure”


Year five: chaos. The client suddenly acquired another major healthcare company. No internal memo: just breaking news on local TV. We were told to shut down the site.


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.


  • Decommissioned or transferred 44 GxP systems.
  • Communicated plans to 2,500 staff while staying on schedule.
  • Closed the site under a brutal timeline.
  • Locked the doors behind us.

WHAT WE BRING

communication

We listen. We talk. We adapt—whether it's a presentation, document, or a conversation.

compliance

To us, it means more than rules. It’s where creativity lives.

project management

Big or small. Local or global. No excuses. We deliver.

strategy

Think. Act. Do.™ We map goals, identify threats, and design a path forward.

people management

We adapt to you—and your teams. We’ve seen it all.

informatics

We connect data, systems, and healthcare seamlessly.

knowledge
20+ years in the trenches.
We know systems, validation, regulations:
GLP, GMP, HIPAA — you name it.

THINK. ACT. DO. ™

Our signature framework for success.

AgileCSV ™

The game-changer. Combining Agile and Waterfall for CSV excellence.

Our experience includes
  • Project & portfolio management
  • Quality systems development
  • Computer system validation
  • Total IT compliance solutions
  • Lab equipment qualification
  • Facility commissioning & qualification
  • Vendor/supplier audits in FDA, CLIA, SOX, HIPAA settings

    THE WAY of BIGGSB


  • NO Billable Hours
  • NO Pass Through Expenses
  • NO Change Orders
  • NO Missed Deadlines
  • NO Go-Live Delays
  • NO Audit Observations

We provide end-to-end compliance and project management for modern Life Sciences companies.

pfizer
2566120
bruker
sharepoint

contact details

Tel:

+1 650-204-1869

E-mail:

[email protected]

Website:

www.biggsb.com

Want to discuss your ideas?

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