Engagement Models Consulting Projects

Put your consulting 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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Execute projects on-time and on-budget by outsourcing your project work to the industry's best consultants.

Need an 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 dedicated account management each step of the way.

Unlock cost efficiencies while utilizing the expertise of the industry's top specialists. Our 95% client success rate and 97% client satisfaction rate speak for themselves. We ensure you get the knowledge and expertise you need so you can focus on the future.

Our services are backed by a Total Quality Guarantee.

Achieve faster project completion.

Access to outsourced resources accelerates the completion of project tasks.

Protect your budget.

Cut overhead and secure competitive rates.

Tap into the industry's top talent.

Lift the constraints of an internal team to utilize skills and competencies from experienced third-party professionals.

Service Area Quality Assurance

Find quality system gaps and close them with the industry's best auditors and remediation experts.

Quality Management Systems (QMS)

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

  • GxP Audits (GMP, GLP, GCP, etc.)

  • QMS Process & Procedure Development

  • Gap Assessments

  • QMS Remediation

  • Quality Unit Resourcing

Auditing Services » Remediation Support »

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 Responses & Remediation

  • PAI & Inspection Readiness

  • Internal Audit & Remediation Services

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Service Area 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.

Regulatory Submissions & Other RA Consulting Services

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.

Contact us » Regulatory Submission Services »

Service Area Validation, Commissioning, and Qualification

Need third-party project or resourcing assistance to support commissioning, qualification, and/or validation activities? We provide the expertise and capability you need to fill any role or complete any project no matter which phase it's in.

We develop and execute scalable resource plans to support validation efforts throughout the project lifecycle. From 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

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Service Area Chemistry, Manufacturing, and Controls (CMC)

We help you achieve your next milestone by offering our expertise in all aspects of CMC development, including product, process and test method development, product stability testing, phase-appropriate validation, packaging development, and manufacturing and testing under GMP conditions.

  • CMC Strategy Development and Management
  • Drug Substance Process Development
  • Drug Product Formulation and Process Development
  • Analytical Development
  • CMC Regulatory Support
  • Biologics Development
  • Supply Chain Management
  • Quality Assurance and Control
  • Manufacturing Process Optimization and Technology Transfer

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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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Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Talent Selection Process

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

Specialist 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 project requirements throughout the life sciences, 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 project needs. We help clients secure a wide variety of life science resources for project-based engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.