Services

Quality & Regulatory Support

The Quality Assurance Services Department of Norac Pharma is staffed by a group of experienced, highly motivated, and well-trained individuals in the fields of quality assurance, compliance, regulatory affairs, and validation. A fully developed team is in place to ensure conformance to all regulatory requirements, internal specifications, procedures, and most importantly, that work results in a quality product that fully satisfies the customer's needs, expectations, and timelines.

Quality Assurance/Compliance capabilities:

  • thorough understanding and knowledge of cGMP regulations and practices
  • adherence to 21CFR 210, 211, and ICH Q7A 
  • implementation of modern quality and critical compliance systems 
  • extensive training programs 
  • documentation review and approval process 
    supplier qualification program 
  • internal audit program staffed by ASQ Certified Quality Auditors
  • prospective validation program (process, cleaning, and computer) 
  • qualification of facilities and equipment (DQ/IQ/OQ/PQ)

Regulatory Affairs Capabilities 

  • FDA, DEA Registered and Inspected Facility 
  • FDA, DEA Interaction and Correspondence 
  • Pre-Approval and Routine Inspection Experience 
  • Drug Master File Development, Submission and Updates 
  • CMC support for Client Drug Applications and Dossiers 
  • Regulatory Affairs Certified Personnel

A corporate commitment to quality and regulatory compliance is demonstrated in all aspects of the pharmaceutical operations: encompassing process development and scale up, pre-clinical and clinical supply, and commercial API production.

Norac Pharma Quality Assurance Services consists of a supportive and experienced team that helps to deliver products and services of the highest quality and value to the customer.