FDA CONSULTING SERVICES Connect with the industry's top FDA consultants... Guaranteed.

Navigate the regulatory process and the entire product lifecycle with the help of the industry's top RA/QA/Clinical consultants.

We help 17 of the top 25 global pharma, medical device, and biotech manufacturers move their products to market and keep them there.

Tap into our global network of over 2,500 resources, over 225 of whom are former FDA. We assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality AssuranceRegulatory Affairs, and Clinical Operations.

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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.

Navigate the entire regulatory process with ease.

The entire process from the first call to the agency to the final approval of your application is a multidisciplinary and complex process.

Our team of former FDA and industry experts helps you navigate the regulatory challenges in bringing your idea for a novel product in front of the regulatory agency to obtain approval to market.

You will obtain approval for your product staying within budget and in the shortest possible time—maximizing ROI in the process.

Ensure first-attempt submission success.

A refusal to receive (RTR) or a refuse to accept (RTA) for an application can have a significant cost in terms of both money and time (delays in product approval and launch) for your development program and your company. Can you afford this preventable cost to your company?

We emphasize a right-first-time approach to ensure you stay within budget and timeline. Our experts are meticulously selected to provide a breadth and depth of experience that matches your needs.

 

Get expert assistance in every stage of the product lifecycle.

Get direct access to the specialized life science talent you need to bring products to market and keep them there.

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidance, and best practices related to quality system management throughout the regulated life science industries.

Fill in-house staffing gaps and scale your quality assurance function to meet changing demands. Cost-effectively acquire the talent you need, where you need them through contracted staff augmentation, FTE recruitment, or managed project support.

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  • The FDA Group, LLC, Compliance Consulting, Westborough, MA
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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:

  • Consulting projects
  • Staff augmentation
  • FTE recruitment

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Regulatory Submissions

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.

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Quality Assurance & Compliance

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

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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

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Access the industry's top talent through the optimal engagement model—consulting projects, staff augmentation, or FTE recruitment.

Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Consulting Projects

Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

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Engagement Model Staff Augmentation

Hire full-time consultants, on contract, for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, test-run your job descriptions, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

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Engagement Model FTE Recruitment

We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

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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

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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 projects 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.