From 510(k) clearance to warning letter resolution — measurable outcomes across every FDA-regulated industry. Each engagement reflects our commitment to getting it right the first time.
Medical device startup seeking first FDA clearance for a novel surgical stapling device.
First-time submission team with no prior FDA experience. Needed predicate device strategy, performance testing plan, biocompatibility assessment (ISO 10993), and submission preparation for a Class II device with software components.
Conducted regulatory assessment, identified optimal predicate device, developed testing strategy, prepared pre-submission (Q-Sub) package, obtained written FDA feedback, then prepared and submitted the 510(k) with complete documentation.
Used Q-Sub meeting to clarify software documentation requirements (IEC 62304) upfront, preventing delays. Implemented ISO 13485 QMS concurrently to support the submission and future compliance.
Pharmaceutical manufacturer facing FDA warning letter for CGMP violations across multiple production lines.
Warning letter citing 8 CGMP violations including inadequate batch record review, insufficient cleaning validation, failed stability studies, and deficient CAPA system. Company at risk of consent decree and import alert.
Developed comprehensive 15-day response strategy, implemented corrective actions for all 8 observations, rebuilt CAPA system, conducted cleaning validation studies, and prepared the facility for follow-up inspection.
Prioritized observations by severity, addressed highest-risk items first, provided daily progress reports to management, and conducted three mock inspections before the FDA returned for re-inspection.
Regional food processing company needing full FSMA compliance before FDA inspection.
Multi-line food processor with outdated HACCP plan, no written food safety plan meeting FSMA Preventive Controls requirements, and an FDA inspection expected within 6 months.
Conducted hazard analysis for all product lines, developed FSMA-compliant food safety plan with preventive controls, supply chain program, and recall plan. Trained staff as Preventive Controls Qualified Individuals (PCQI).
Leveraged CFSQA credential to audit existing processes, identified gaps against 21 CFR Part 117, implemented corrective actions prioritized by risk, and validated through internal audits before FDA arrival.
Supplement manufacturer preparing for first FDA inspection with significant 21 CFR 111 gaps.
Growing supplement company lacking identity testing of incoming ingredients, incomplete batch records, no formal complaint handling system, and missing master manufacturing records for 15 SKUs.
Implemented 21 CFR 111 CGMP system including identity testing program (HPTLC and HPLC methods), master manufacturing records, batch production records, complaint handling SOP, and vendor qualification program.
Phased implementation over 5 months: identity testing first (highest enforcement priority), then production records, then supporting systems. CPGP credential ensured pharmaceutical-grade rigor applied to supplement manufacturing.
European medical device manufacturer entering the U.S. market for the first time.
EU-based manufacturer with CE marking but no FDA experience. Needed U.S. market entry strategy including establishment registration, device listing, 510(k) clearance for 3 Class II devices, and U.S. Agent designation.
Served as U.S. Agent, completed FDA establishment registration, device listing for all products, and managed 510(k) submissions for three Class II devices. Bridged EU technical files to FDA submission format.
Leveraged existing CE technical documentation to accelerate 510(k) preparation. Identified predicate devices, mapped EU Essential Requirements to FDA requirements, and prepared performance data summaries for FDA review format.
Every engagement starts with a free consultation. Tell us about your FDA challenge, and we'll outline a clear path to compliance.