FDA Consulting Services and Training
Navigating FDA regulations with precision. We provide comprehensive consulting, strategic guidance, and technical support tailored for FDA Regulated industry compliance and operational excellence.
FDA Consulting Services
Food and Dietary Supplement Requirements
- 510k Submissions: Premarket Notification process support for Class 2+ devices.
- Registration & Listing: Expert assistance for Device Listing (LST) and Establishment Registration (REG).
- Compliance Review: Labeling and regulatory requirement audits to identify and fix issues.
- Food Facility Registration: FDA requires biennial registration of food facilities. We assist with the entire registration process.
- Seafood and Juice Hazard Analysis Critical Control Points (HACCP)
- Current Good Manufacturing Practices (cGMPs)
- VQIP Implementation: Strategic support for the Voluntary Qualified Importer Program to achieve expedited entry and shorter hold times.
- Food Traceability (FSMA 204): Early adoption strategies to ensure compliance before the July 2028 enforcement deadline.
- FCE & SID Registration: Expert assistance for manufacturers of low-acid canned food (LACF) and acidified foods with facility and process filings.
- Preventive Controls for Human Foods - Plan Review, Training, Implementation
- Product Labeling Review - We help ensure your product labels are FDA Compliant.
- Product Claims Review - We'll review your dietary supplement claims to ensure complaince with FDA Regulations.
- Prior Notice - We can assist you with Prior Notice for Imported Foods.
Foreign Supplier Verification Programs (FSVP)
Expert FDA Help is THE authority on FSVP compliance. Our owner has conducted 150 FSVP inspections with the FDA and serves as a Lead Instructor for FSPCA FSVP training, so you receive guidance from someone who understands exactly how FDA enforces these requirements.
- FSVP Program Review
- Mock Inspections
- Support during FSVP Inspections
- FSVP Program Development
- FSVP Templates
- 483a Response
- FSVP Importer Services - We are listed as the FSVP Importer and handle everything on your behalf from FSVP Plans, Inspections, etc.
- Produce Safety Rule - 21 CFR Part 112 Compliance
- Dietarty Supplement FSVP
FDA Import Assistance
- Hold Resolutions: assistance with FDA detentions and releases.
- List Removal: Petitions to remove products from the Import Alert "Red List".
- Green List Addition: Expedited placement on the "Green List" to bypass automatic detention.
- We can help you with any FDA regulated commodity offered for import.
Drug Requirements
Drug facility registration and comprehensive drug listing to ensure FDA information is current. We perform detailed regulatory requirement and label reviews to maintain high compliance standards.
Does your state need help achieving lower drug prices? Inquire within on how we can help your state with the Section 804 Importation Program (SIP).
Cosmetic Requirements
Strategic review of cosmetic regulatory requirements and labeling audits to identify compliance gaps and provide actionable correction insights.
- 510k Submissions: Premarket Notification process support for Class 2+ devices.
- Registration & Listing: Expert assistance for Device Listing (LST) and Establishment Registration (REG).
- Compliance Review: Labeling and regulatory requirement audits to identify and fix issues.
Medical Device Requirements
Training
We offer public and private training. Book below for public training. Inquire about private training.
Foreign Supplier Verification Programs (FSVP) Training
Upon successful completion of the FSPCA FSVP Course, you will receive a certificate showing you have the necessary training to be considered a Qualified Individual (QI). This course is offered to you by a former FDA Import Specialist who conducted 150 FSVP inspections, and has the knowledge and insight you won't gain elsewhere. Click the button below to register and pay to reserve your space in the class.
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Preventive Controls (PC) For Human Foods
Upon successful completion of the FSPCA Preventive Controls for Human Foods Course, you will receive a certificate showing you have the necessary training to be considered a Preventive Controls Qualified Individual (PCQI). This course is offered to you by a former FDA Import Specialist who has a deep understanding of FSMA and FDA's regulatory approach. Click the button below to register and pay to reserve your space in the class.
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