Custom Services for the FDA Approval Process

The majority of Americans are now using nutraceuticals, and the industry and FDA are working to create a freer flow of information on product safety and quality assurance. Axon Nutritionals is dedicated to safety and has an array of analytical services, preclinical development services, and drug design services to help other companies bring safe nutritional products to market that comply with all regulatory requirements.

In-line with our mission, Axon Nutritionals offers academics and other small businesses in the nutraceuticals and pharmaceuticals industries access to our robust analysis and safety assessment program for submission to regulatory agencies.

Regulatory Medical Writing Services

Many companies need help with the FDA approval process, which is why we provide specialized regulatory medical writing services that supply:

• Regulatory support for FDA filings
• Regulatory support marketing claims
• Literature summaries
• Applications to FDA to investigate a new drug
• Documents intended for review by institutional review boards

Our medical writers are members of the American Medical Writers Association, are enrolled in the organization's ongoing certificate programs, and have developed documents for nutraceutical and pharmaceutical companies that have pushed products from preclinical and clinical trial phases through the FDA approval process.

Analysis and Safety Assessment Program

Our analysis and safety assessment program services can be customized to meet the product development and analytical laboratory services needs of nutraceutical and pharmaceutical companies:

• Drug Development Services
• Clinical Laboratory Services
• Nonclinical Testing Services
• Analytical Testing Services
• Nutritional Analysis Services
• Ingredient Verification Services

A large part of our business centers on providing companies with safety and quality assurance, which is why we offer analytical testing services to detect impurities, mytotoxins, and other harmful contaminants:

• Melamine Testing
• (Bisphenyl-A) BPA Testing
• Ochratoxin A Testing

Axon Nutritionals is at the forefront of bridging the gap betwen industry and FDA; contact us for more information regarding our comprehensive analysis and safety assessment program to make certain your products will be approved and in compliance with current regulatory requirements.