Dietary Supplements

Overview

Dr John Atwater has experience working with over 30 different dietary supplement manufactures and private brand owners, helping ensure that they complied with dietary supplement regulatory requirements, and helping them improve the quality of the products they manufactured. Dr Atwater’s work was integral to the development and implementation of 3 of the primary dietary supplement certification programs, including USP DSVP, GRMA and SSCI. 

At ARS, our team has the scientific knowledge and expertise to assist in the development of new products including nutritional (e.g., vitamin, mineral), botanical (e.g., Echinacea, Turmeric, Ashwagandha), nonbotanical (e.g., ubidecarenone, chondroitin sulfate sodium), and probiotics (e.g., single- and multi-strain) supplements.  We can work not only with technically sophisticated manufacturers that strive for continual improvement, but also relatively new and inexperienced companies that require additional support to achieve their strategic goals.

Ataqua Regulatory Services can provide assistance with:
Good Manufacturing Practices

Compliance with FDA GMP regulations in 21 CFR part 111 and/or USP general chapter <2750> by:

  • Assisting with the development and implementation of standard operation procedures for all your 6 GMP quality systems;
  • Conducting GAP GMP audits to inform you as to what improvements are needed to comply with GMP requirements;
  • Conducting thorough and complete GMP audits of all 6 GMP quality systems to help ensure full compliance to FDA GMP regulations;
  • Conducting mock third-party inspections for staff training and preparing for a third-party certification program (e.g., USP DSVP, GRMA, SSCI) audit.
    • Third-party Certification Programs
      • USP Dietary Supplement Verification Program (USP DSVP)
      • Global Retailers Manufacturers Alliance (GRMA)
      • Supplement Safety Compliance Initiative (SSCI)
Dietary Supplement Product Development

Development of new products by assisting with:

  • Establishing excipients, dietary ingredient and dietary supplement specifications;
  • Developing and improving product formulations;
  • Developing and validating analytical test procedures;
  • Designing and reviewing product labels for compliance to federal and state labeling regulations, including dietary ingredient quantitative claims and health claims (e.g., structure function, qualified health claims).Therapedic® MICROBAN® Waterproof

Supplier Qualification

ARS can help you develop and implement an effective supplier qualification program for your suppliers of excipients and dietary ingredients, and your contract manufacturer and laboratory services providers by:

  • Establishing standard operating procedures for qualifying your suppliers;
  • Preparing quality agreements with your suppliers;
  • Conducting thorough and complete GMP audits of your suppliers.