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Quality & Regulatory Compliance: Consulting & Specialized Staffing

Quality & Regulatory Compliance Experts for Life Sciences

Bridgepoint provides Quality & Regulatory Compliance consulting and specialized staffing for pharmaceutical, biotech, and medical device companies, including the CDMOs and CMOs that serve them. Bring us in as a project team, or add an experienced consultant to your own team for interim, contract, or surge needs.

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Consulting & Project SupportI need a project team Specialized StaffingI need a consultant on my team
Bridgepoint capability statement, page 1
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We work on quality systems, audits, remediation, inspection readiness, and computer system validation.

Regulatory Frameworks
Why the Screening Matters

This work is easy to describe and hard to do well.

Plenty of people can explain GAMP 5. Fewer have written the validation documents for a live GxP system and then had to defend them during an FDA inspection.

Take an SAP S/4HANA upgrade at a site the FDA is watching closely. The person running validation has to decide what is critical, what can be justified on risk, and what has to be tested again. Someone who has made those calls before will usually spot the problems in the first week. Someone who has not may not see them until an investigator does.

Before a consultant starts on your project, we have them walk us through work they have actually done. Which documents did they write? Which ones did an auditor question? How did they answer? We have done enough of this work ourselves to know what a good answer sounds like.

Our Services
How We Work

Consulting & Specialized Staffing

Some clients need a project run for them. Others have the structure and need more people. We do both.

SERVICE 01

Consulting & Project Support

Use this when the work needs its own structure. We put the team together, set milestones, and report against them until the deliverables are done. A validation program with a fixed deadline is a typical example.

System ValidationCompliance ProjectsProject Oversight
SERVICE 02

Specialized Staffing

Use this when you have the structure but not enough people. Our consultant joins your team, reports to your managers, and follows your procedures. We stay involved after they start.

Interim ExpertsProject SupportSurge Capacity
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Specialized Staffing

Roles We Support

These are the roles clients ask us for most often. Our consultants are used to working without much supervision.

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01

We Start With the Problem

Before we talk about people, we want to understand your situation: what systems you run, what your last few audits found, and what is driving the timeline. A 483 response and an ERP upgrade call for different experience, even when the job titles look the same.

02

We Know What the Work Requires

We have seen how quality and validation work goes wrong in regulated environments. That is how we can tell whether a consultant has done the work or has only been near it.

03

We Work to the Agency's Dates

If you are going to respond to a Form 483, FDA expects the response within 15 business days. Warning letter commitments and pre-approval inspections come with dates you cannot move either. We take the date as fixed and plan backward from it.

Life Sciences Sectors Served

Who We Work With

We work with companies where a quality failure can reach a patient.

PharmaceuticalDrug Manufacturing BiotechBiologics & Biosimilars Cell & GeneAdvanced Therapies Medical DeviceISO 13485 / QMSR CDMOs / CMOsContract Mfg. GxP OperationsGMP / GLP / GCP
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Join Our Consultant Network

Quality, Compliance & Validation consultants in life sciences.

If you work in quality, regulatory compliance, or validation in life sciences, send us your background. When we have an engagement that fits, we will call you to go over the scope.

Submit Your BackgroundConsulting Opportunities

Bring us your compliance challenge.

If we can help, we will explain how. If we cannot, we will tell you that too. Schedule a call to discuss your project, timeline, and staffing needs.

Discuss Your Need Call (715) 564-4480