Services Regulatory Affairs

The regulatory landscape is constantly changing. Our large staff of former FDA and industry experts ensure you stay on top of it all. Whether you need help preparing submissions or need to staff your internal team with an experienced expert, we help you navigate complex regulatory challenges, bring your products to market, and keep them there.

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FUNCTIONAL AREA Regulatory Submissions & Resourcing

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.

Engagement Models

 
We provide services and support via three engagement models. Get managed support for outsourced projects as well as contingent or direct hire candidate search and placement. We specialize in the entire range of the recruiting process, giving you a breadth of resources and expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Managed Projects

Put your projects in the hands of qualified third-party experts. Outsourced project-based 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

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, 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 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 aggressive and complicated 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

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of regulatory requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


Please contact us to learn more about fulfilling specific regulatory affairs resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.