FDA CONSULTING SERVICES Connect with the industry's top FDA auditing and remediation consultants.

Join the thousands of drug, device, and biotech companies achieving and maintaining GMP compliance with The FDA Group.

17 of the top 25 global life science companies trust The FDA Group to connect them with the GMP experts they need to execute projects and ensure compliance on time and on budget.

Tap into our global network of over 2,500 resources, over 225 of whom are former FDA, to fulfill all of your mock FDA audit, GMP, GCP, GLP, and other compliance assessment needs. We assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

Tell us a little about your resourcing needs or simply indicate you'd like a call-back to discuss your project. We'll follow-up within one business day.

Let's get started. Talk to us.

Tell us a little about your resourcing needs or simply indicate you'd like a call-back to discuss your project.

We'll follow-up within one business day.

Access exclusive life science focus and expertise.

Unlike big consulting firms, we’re armed with firsthand experience working in the roles where the subtle details make all the difference—accelerating the process of finding the right GMP resource the first time.

Tap into a vetted auditor network.

We fully understand your resourcing needs and employ our proprietary talent selection process to provide the resources you need, at a competitive rate, with dedicated account management every step of the way. Our 95% client success rate speaks for itself.

Work with former FDA professionals.

With a staff of former FDA professionals, we are sure to have the appropriate professional(s) for your project.

Auditing & Remediation Services

Need a traditional consultant or outsourced project partner you can rely on? We draw on a large pool of the industry's best talent to help life science companies execute projects from start to finish with or without dedicated account management each step of the way.

Unlock cost efficiencies while utilizing the expertise of the industry's top specialists. We ensure you get the knowledge and expertise you need so you can focus on the future.

Mock FDA Inspections/Audits

Inspections by the Food and Drug Administration can be challenging. If the company fails, the FDA can issue them a warning letter or, in extreme cases, shut down the company’s operations entirely. Because the consequences of noncompliance are serious, many executives would like to know where the issues lie beforehand.

As such, they may choose to consult with an outside firm to conduct a mock inspection. These inspections can help identify any issues that the executive might have beforehand regarding compliance with the FDA regulations.

GMP Auditing Services

Our quality professionals bring direct experience in pharmaceutical, biotechnology, combination, and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of product development.

Our team works closely with your staff to improve processes for manufacturing, distribution, and packaging facilities.

Our quality professionals take the lead in planning, executing, and analyzing comprehensive audits to uncover potential deficiencies and make the necessary improvements, all while empowering your staff to maintain compliance well into the future.

Our GMP auditing services include:
- Mock Pre-Approval Inspections (PAI) and mock FDA audits
- Mock Notified Body Inspections
- Mock recalls
- Vendor/supplier audits
- MDSAP audits
- Formal risk assessments & risk mitigation strategies
- Quality system & corporate SOP gap analysis
Additionally, we assist in:
- Compliance master planning and strategy
- Corrective actions and implementation plans
- Planning and execution of remediation projects
- Validation and qualification
- Quality system & corporate SOP guidance and development
- Training and development of training programs
- GCP Auditing
- GLP Auditing
- Vendor/Supplier Auditing
- Pharmacovigilance Auditing
- Data Integrity Auditing

Compliance Remediation

Concerned your quality system doesn't reflect FDA expectations? Our active remediation model goes beyond consulting to solve a variety of compliance problems while offering ongoing project management and training services each step of the way. Once remediation is complete, we plan, implement, and audit your quality system to ensure regulatory compliance is maintained well into the future.

Our 4-Step Approach to Remediation

Analyze observations and choose the quality investigation model best suited to thoroughly understand the compliance issues at hand.
Launch an internal investigation with the assistance of key stakeholders to assess all affected processes and reveal the root causes of noncompliance.
Draft a comprehensive remediation plan and assure agreement by all stakeholders.
Implement agreed-upon corrective and preventive actions with the appropriate amount of supervision and monitoring.

Our compliance remediation services include:

Regulatory Observation/Warning Letter Responses & Remediation
PAI & Inspection Readiness
Internal Audit & Remediation Services
Non-Conformance/Deviation Investigation Management Support
Process Analysis & Enhancement
Investigation, Action Plan, & Effectiveness Check

Third-party remediation professionals offer a fresh perspective while working diligently to analyze gaps, identify root causes, resolve compliance problems, and communicate your efforts to regulators effectively.

You deserve an auditing partner that lives and breathes life science.

We are that partner.

We don’t spread ourselves thin across various industries. Instead, we focus on providing a deeper, richer bench of life science talent at the rate you need. Our large staff of internal resources and extended global network offer access to specialists wherever you need them.

We help thousands of firms, including 17 of the top 25 global pharmaceutical, biotech, and medical device companies, connect with the specialists they need, when and where they need them, through the optimal workforce model.

Why work with The FDA Group?

Exclusive life science focus and expertise
Dedicated account management team
Right resource, first time (95% success)
97% client satisfaction
Total Quality Guarantee

Our Proven Process

Introductory Conversation

About Us
About You
Scope Of Work

Resources Definition

Background And Expertise
Location Of Resource
Rate Rightsizing

Proprietary Resource Selection Process

Recruiting Team External Search
In-House Subject Matter Experts
Resource Identification

Resource Presentation

CV And Rate
Perfect Match Summary
Interview Call Coordination

Agreement Processing

MSA And Addendums
Supplier Qualification
Kickoff Coordination

Account Management

Project Management Of Resource
Satisfaction Management For Client
Total Quality Guarantee

Our services are backed by a Total Quality Guarantee. If for any reason, you are dissatisfied with any service, we will provide you with a full refund.

Join the thousands of life science companies executing their audits with The FDA Group.

Tell us a little about your resourcing needs or simply indicate you'd like a call-back to discuss your project.

We'll follow-up within one business day.

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