Experience You Can Count On

Get your business aligned in a credible, timely manner with required FDA compliance and necessary regulations. With our guidance and support, you will deliver safe and quality products to your clients and remain consistently compliant and successfully competitive.

 

WE OFFER MORE THAN CONSULTING

We come alongside you, simplify FDA regulations, TEACH, and MENTOR your teams. We create ROBUST Quality Management Systems.

Get a Complimentary 30-Minute Consultation

Don’t wait for unannounced FDA inspections and resulting violations to catch you off guard. Now is the time to prepare your business.

    EXPERIENCE YOU CAN COUNT ON

    Increase your company growth, prevent FDA violations and Warning Letters, avoid potential Product Recalls, and get on a solid compliance path to industry visibility, secure contract manufacturers and supply chain partnerships, and have lasting satisfied customers.

    OUR MISSION

    • Help your business credibly and quickly align with required compliance and necessary FDA regulations.
    • Work collaboratively with you to deliver safe and quality products.
    • Provide guidance to help you maintain a competitive edge through consistent compliance.
    • For over 20 years we have consulted with small, mid-size, and large corporations, and have led in the industry with integrity and excellence.
    • Our expert consulting goes beyond supplement manufacturers, co-packers, and distributors, and extends to the supporting supply chain segments upstream and downstream.
    • We provide effective FSMA (Food Safety Modernization Act) and FSVP (Foreign Supplier Verification Program) guidance across the board for ingredient suppliers.
    • We are less than 50 minutes from all major airports and can easily access major routes for convenient travel to US and International clients.
    • Our focused approach is designed to empower your teams and outfit them with the effective compliance tools they need to succeed.

    PROVIDED SERVICES

    Backed by 30+ years of industry expertise, DF Guardian is always prepared to help your business.
    See how we can serve your dietary supplement and food & beverage company.

    • QUALITY
      CONSULTING

      Establish Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP) from the very start, receive onsite mock audits, and implement quality agreements and lab qualifications.

    • Regulatory & Compliance Consulting

      Receive third party audit preparedness consulting and learn how to adhere to Food Safety Modernization Act (FSMA) rules, comply with Foreign Supplier Verification Program (FSVP) requirements, respond to FDA 483’S, assist with product recalls and FDA warning letters, and more!

    • Supply Chain Consulting

      Learn how to decipher technical and legislative regulatory language, create beneficial contract partnerships, and appropriately qualify suppliers.

    • Regulatory Leadership Programs & Training

      Invest in high-level industry training that will prepare your business to make sound decisions and work more effectively. Our team of instructors are equipped to professionally teach, mentor and coach your employees, onsite or virtually, and to improve your internal efficiency.

    Frequently Answered Statements

    Hiring a consultant is expensive.

    This is a worthwhile investment up front. You’ll ensure compliance that will save you by preventing costly FDA 483s and Product Recalls.

    I’m a small business, I don’t need this.

    Regulations apply whether you’re a large or small company. No matter your company size, we provide the same level and value of excellence for the investment.

    I’m only a distributor, I don’t need consultancy.

    If your company name is on the label as the Distributor, the FDA says, you’re “ultimately responsible” for all aspects of your finished product. We’ll educate you.

    I’ve used my raw material suppliers for years and they handle everything, I’m good.

    Raw material suppliers must comply to their specific regulations. Although they are expected to meet their compliance and provide quality support of your product, this is a false assumption until you verify them.

    I have GMP certification, I’m compliant.

    GMP certified companies have failed FDA audits; and even had product recalls. GMP certification does not constitute compliance. The FDA expects conformance to all applicable regulations. We provide expertise.

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