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.