3 Oak Road 
Fairfield, NJ 07004

973-276-9600
844-740-7500

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Quality And Integrity

Leading Pharma’s regulatory and quality control team oversees the quality and safety of our products from the initial stage through their arrival to the customer.

This process includes:

  • collaboration with manufacturers to ensure compliance with FDA standards; 
  • assistance with the qualification of API suppliers; 
  • advice regarding U.S. regulatory requirements; 
  • pharmacovigilance and a set of standard operating procedures (SOPs) to ensure safety and consistency every step of the way; 
  • cGMP compliance audits of business partners and manufacturers;
  • oversight of the labeling process to comply with FDA standards; and
  • full product launch support.

Leading Pharma is dedicated to providing quality medicines that are accessible and affordable for patients who need them.