FDA Regulatory Consulting

FDA Consultant
Expert FDA Regulatory
& Compliance Services

From FDA registration to warning letter remediation — comprehensive FDA regulatory consulting across drugs, medical devices, food, and dietary supplements. Navigate the FDA with confidence.

Jared Clark, JD, MBA, PMP, CMQ-OE, RAC, CPGP, CFSQA

Schedule Free Consultation (858) 240-4353

FDA regulatory consulting is a core specialty of Certify Consulting, our full-service certification and compliance practice.

200+
Clients Served
100%
First-Time Pass Rate
8+
Years FDA Experience
5
FDA Centers Covered
RAC
Regulatory Affairs Certified
RAPS — Pharmaceuticals specialty. One of the highest regulatory credentials available.

Comprehensive FDA Consulting Services

From your first FDA registration to ongoing compliance management — expert guidance across every FDA regulatory requirement.

FDA Registration

Facility registration, product listing, and U.S. Agent services for domestic and international manufacturers.

Inspection Prep

Mock inspections, documentation readiness, employee interview preparation, and real-time inspection support.

Warning Letters

Strategic response development, CAPA implementation, and consent decree prevention within FDA timelines.

510(k) Consulting

Predicate selection, submission strategy, performance testing, and pre-submission (Q-Sub) meeting support.
View All FDA Services

Every FDA-Regulated Industry.
One Expert Practice.

The FDA regulates products that account for about 20 cents of every consumer dollar spent in the United States. Whether you manufacture pharmaceuticals, medical devices, food products, or dietary supplements — your business is subject to FDA oversight. We provide regulatory consulting across all five major FDA centers.

Explore Industries
CDER

Drugs

Prescription, OTC, and generic drugs. ANDA/NDA submissions, CGMP, labeling.

CDRH

Medical Devices

Class I/II/III devices. 510(k), PMA, De Novo, QMSR, UDI compliance.

CFSAN

Food & Supplements

FSMA compliance, HACCP/HARPC, dietary supplement CGMP (21 CFR 111).

CBER

Biologics

Blood products, vaccines, gene therapy. BLA submissions, biosimilars.

Our FDA Consulting Approach

A structured, phase-based approach to FDA regulatory compliance — because navigating the FDA shouldn't feel like guesswork.

1

Regulatory Assessment

We evaluate your products, facilities, and current compliance posture to identify gaps and determine the optimal regulatory pathway.

2

Strategy Development

A clear regulatory roadmap with milestones, timelines, and deliverables — tailored to your product category and business goals.

3

Documentation & Systems

SOPs, quality system documentation, submission packages, and compliance records built to FDA expectations.

4

Implementation

Hands-on support to implement corrective actions, establish processes, train staff, and prepare for FDA scrutiny.

5

FDA Interaction

Pre-submission meetings, inspection support, 483 response strategy, and warning letter remediation when needed.

6

Ongoing Compliance

Post-market surveillance, annual registration renewal, adverse event reporting, and continuous compliance monitoring.

Why Work with
Jared Clark?

A unique combination of legal training (JD), business acumen (MBA), project discipline (PMP), and deep FDA regulatory expertise — backed by the credentials that matter most in FDA-regulated industries.

  • RAC — Regulatory Affairs Certification (Pharmaceuticals) from RAPS
  • CPGP — Certified Pharmaceutical GMP Professional from ASQ
  • CFSQA — Certified Food Safety & Quality Auditor from ASQ
  • CMQ-OE — Certified Manager of Quality/Organizational Excellence
  • 200+ clients served across all FDA-regulated industries
  • 100% first-time audit pass rate across all engagements
JD
Juris Doctor — Legal expertise for regulatory compliance and enforcement defense
MBA
Master of Business Administration — Business strategy meets regulatory reality
RAC
Regulatory Affairs Certification — The gold standard in pharmaceutical regulation
CPGP
Certified Pharmaceutical GMP Professional — FDA CGMP expertise
CFSQA
Certified Food Safety & Quality Auditor — FSMA and food facility expertise
PMP
Project Management Professional — On-time, structured regulatory projects

Frequently Asked Questions

Common questions about FDA consulting, regulatory compliance, and how we can help your business.

Look for FDA consultants with regulatory affairs credentials (RAC), direct experience in your product category, and a track record of successful FDA interactions. Ask about their experience with your specific regulatory pathway — whether that's 510(k) clearance, facility registration, or warning letter remediation. A good FDA consultant should explain your options in plain language and provide references from similar engagements.
Costs vary based on scope. Simple FDA facility registration: $2,000–$5,000. Comprehensive 510(k) submission support: $25,000–$75,000. Warning letter remediation: $15,000–$50,000. Ongoing compliance retainers: $3,000–$8,000/month. We provide detailed scoping and fixed-fee quotes for every engagement — no surprises.
An FDA consultant helps companies navigate FDA regulatory requirements — from initial facility registration and product listing through ongoing compliance management. This includes preparing for FDA inspections, developing regulatory submissions (510(k), PMA, ANDA/NDA), responding to FDA enforcement actions like warning letters, and establishing quality systems that satisfy FDA CGMP requirements.
During an FDA inspection, investigators examine your facility, quality system documentation, manufacturing processes, complaint handling, CAPA procedures, and records. If deficiencies are found, the investigator issues Form 483 observations at close. You have 15 business days to respond. Serious or repeated deficiencies can escalate to warning letters, consent decrees, or import alerts. Learn about our inspection preparation services →
The FDA's target review time is 90 days (FDA Decision Day), but total timeline from start to clearance is typically 6–12 months. This includes predicate device research, testing, submission preparation, and FDA review. Factors that extend the timeline include additional information requests and clinical data requirements. A pre-submission (Q-Sub) meeting with FDA can help clarify requirements upfront. Learn about our 510(k) consulting →
View All FAQs

Ready to Navigate the FDA with Confidence?

Schedule a free consultation with Jared Clark, RAC. Whether you're preparing for an inspection, responding to a warning letter, or bringing a new product to market — we'll help you get it right.

Schedule Free Consultation (858) 240-4353