Ratings
0.0
Based on 0 verified reviews
Industry Knowledge
0.0
Hiring Speed
0.0
Candidate Quality
0.0
Candidate Experience
0.0
Communication
0.0
Value For Cost
0.0
Company Description
The FDA Group is a specialized life sciences consulting and resourcing partner that helps FDA-regulated companies access top-tier Regulatory Affairs, Quality Assurance, and Clinical Operations expertise precisely when and where its needed. Through two flexible engagement modelsproject-based consulting with dedicated project management and staff augmentation with embedded subject matter expertsthe firm delivers strategic guidance and hands-on execution across the full product lifecycle, from clinical development through commercialization. Its service areas span audits and mock inspections (including GMP, GLP, GCP, GCLP, CSV, Quality System, supplier/vendor, gap assessments, data integrity, clinical site, MDSAP/ISO, pharmacovigilance system, QMSR, and REMS), regulatory submissions and meeting support (IND, 505(b)(2), ANDA, 510(k), Q-Sub/pre-submission, and FDA meeting preparation for both drugs and devices), remediation and regulatory action response (quality system remediation, CAPA implementation, QMS rebuilding, data integrity and facility compliance remediation, Form 483 and Warning Letter response, consent decree support, and import alert resolution), as well as quality management systems, documentation/SOP development, validation and qualification (process, computer system, and method), and specialized programs such as EU MDR/IVDR and 503B compounding pharmacy compliance. A global network of experienced industry practitioners and former FDA personnel allows the firm to rapidly match hyper-specialized consultants and interim leaders to client needs, whether for short-term initiatives or longer embedded assignments. Each engagement is supported by dedicated account management, internal QA oversight, and a Total Quality Guarantee offering a full refund if services do not meet expectations. Since 2007, The FDA Group has continuously curated its network to uphold rigorous performance and integrity standards, ensuring clients receive autonomous experts who integrate quickly, operate within client systems, and remain accountable for measurable outcomes. With resources across the U.S. and internationally and an office presence in Boston, MA, The FDA Group provides a reliable, low-risk path to accelerate submissions, strengthen compliance, remediate issues, and scale teams efficiently.
Specialization
Industry Focus
Profile Expertise
Who we worked with
No featured clients provided
No video introduction provided
FAQ
No FAQ provided
Similar Agencies
Whitley Recruiting Partners
0.0 (0)
Raleigh, United States
Software DevelopmentCybersecurity+9
Crown Personnel Services
0.0 (0)
Dayton, United States
AutomotiveAerospace+15
Raven Ridge
0.0 (0)
Bedford, United States
Management ConsultingLegal+11
Search Excellence Partners
0.0 (0)
Chicago, United States
AutomotiveAerospace+19
Covr
0.0 (0)
Springville, United States
Hospital & Health Care (Nursing)Physicians+6
RedLine Associates, Inc
0.0 (0)
Chicago, United States
BankingInsurance+15