Consultants

With a staff of over 1,600 resources worldwide, 125 of whom are former FDA, we are sure to have the appropriate professional(s) for your project. We're also always searching for opportunities to grow our consulting network. Find a resource or apply to join our consulting network below.

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You deserve an FDA consulting 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.

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

Find a consultant »

 

Get expert assistance at every stage of the product lifecycle.

We help life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle.

Expand the sections below to learn more about our consulting services and areas of expertise.

 

Quality Assurance

Quality Management Systems (QMS)

Concerned your quality system doesn't reflect FDA expectations? Connect with former FDA and industry professionals who have extensive knowledge of FDA's current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.

  • GxP Audits

  • QMS Process & Procedure Development

  • Gap Assessments

  • QMS Remediation

  • Quality Unit Resourcing


Non-Conformance & CAPA Management

Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.

  • Non-Conformance/Deviation Investigation Management Support
  • Process Analysis & Enhancement

  • Investigation, Action Plan, & Effectiveness Check 


Regulatory Compliance

Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.

  • Regulatory Observation/Warning Letter Responses & Remediation

  • PAI & Inspection Readiness

  • Internal Audit & Remediation Services

Regulatory Affairs

We'll work with you in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully develop due diligence strategies. Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.

  • Review of client technical dossiers and developmental plans
  • Research and interpretation of regulations
  • Determination of regulatory status
  • Pre-submission review of technical documents
  • Critical writing and review of documentation
  • Clinical trial applications and notifications (IND, IDE, CTX, etc.)
  • Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
  • Orphan Drug, Treatment Use, and ANDA Suitability petitions

Our experts prepare all major regulatory submissions and provide extensive quality control review for all trial-related documentation, such as:

  • Regulatory Agency and IRB/EC submissions
  • Procurement of Import/Export license
  • Initial submissions, amendments, notifications, and closeout submissions

Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:

  • Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
  • Coordinating clinical trial application filings to regulatory agencies
  • Ensuring submissions comply with regulations
  • Managing submissions and document storage processes
  • Staying abreast of all regulations to ensure documentation compliance

Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.

Clinical Operations

Demand for talented clinical operations professionals grows each day. How do you find the resource you need when you need them? Through years of connecting clinical operations experts with opportunities around the world, we’ve developed a large active, and extended pool of talented professionals.

  • Fill in-house staffing gaps and scale your clinical operations to meet changing demands
  • Cost-effectively acquire the talent you need, where you need them
  • Work towards accurate and timely completion of your clinical trials
  • Cut down on administration, better control your overhead, and reduce turnover

We can fulfill clinical contracted and direct hire resource placement needs in a variety of roles and functions including, but not limited to:

  • Clinical Operations
  • Clinical Project Management
  • Clinical Monitoring
  • Biometrics & Data Management
  • Medical Writing

Commissioning, Qualification & Validation

We work with our clients to develop scalable resource plans to support validation efforts throughout the project lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our resources have you covered.

  • Validation Master Plans (VMPs)

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Equipment Validation

  • Software Validation

  • Process Validation

Manufacturing & Engineering

Our resources can evaluate and enhance any link in your manufacturing operations from material receipt to finished product distribution.

Our staff of engineering resources span multiple disciplines to ensure your needs are met. Whether you need to implement a global document control system or develop a package for your product we have the expertise to assist you.

  • Product & Personnel Controls

  • Aseptic Processing

  • Biologics Manufacturing

  • Product Assembly

  • Packaging & Labeling

  • Process Optimization

  • Sterilization

  • Lyophilization

  • Purification

  • Software Engineering

    • System Migration
    • Embedded Device Software
    • Testing
    • Instrument and Device
  • Commissioning and Qualification

    • Equipment
    • Utilities
    • Facilities
    • Factory Acceptance Testing
  • Product, Process and Equipment Engineering

    • Design Engineering
    • Product Development
    • Manufacturing Process Engineering
    • Packaging Engineering
    • Instrument and Control
  • Turn-Key Project Management

    • Project Conception and Feasibility
    • Project Management
    • Project Delivery

Find the life science resource you need.

Use our resource selection tool below to select your area of need and request a consultation using the form below. We will follow up to learn more about your needs and identify a perfect-fit resource(s). Please be sure to restate and describe your need in as much detail as possible to help us locate the right resource(s).

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Apply to join our consulting team.

At The FDA Group, we are always looking for top talent to grow our network. If you can bring experience and new perspectives to our consulting team, we invite you to learn more and connect with us.

Learn more and apply »

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.

Tell us about your consulting needs and get the conversation started.

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

We'll follow up within one business day.