Regulatory & Quality Onboarding Resources
Quality Policy
A2A is committed to providing its customers with safe and effective products. We uphold a strict quality standard and accountability throughout our entire organization. Our Quality Policy has been part of A2A's foundation since the organization's formation. A2A Alliance Pharmaceutical's Supplier Code of Conduct applies to all vendors and suppliers of A2A Alliance Pharmaceuticals and its operating subsidiaries, affiliates, and divisions. It requires that the highest legal, moral, and ethical standards of honesty, integrity, and fairness be practiced in the conduct of A2A Alliance Pharmaceutical's affairs. Read more on the Supplier Code of Conduct page.
Baseline Audit Form (BASEAUDIT-#)
A2A Regulatory conducts thorough Audits on Suppliers to improve compliance and regulatory controls. The audit ensures, at an initial level, that our suppliers are conforming to the requirements set out by regulatory authorities, quality standards, as well as the manufacturer's specifications. It helps to manage risks associated with product quality, safety, and efficacy, ensuring that the supplied pharmaceuticals meet the appropriate cGMP (Current Good Manufacturing Practices) standards. This needs to be completed by Supplier's Authorized Regulatory Representative.
If you have any audit-related questions, please contact the following email: Audits@A2A-AllianceRx.com.
Release Determination Statement (RDS-#)
Release Determination Statement Electronic Submission Link
A2A Regulatory conducts a thorough review and QA/RA Approval for each Production Batch Record to improve compliance and regulatory controls. The Release Determination Statement helps to manage risks associated with product quality, safety, and efficacy, ensuring that the supplied pharmaceuticals for each Lot meet the appropriate cGMP (Current Good Manufacturing Practices) standards. This needs to be completed by the Supplier's Authorized Regulatory & Quality Representative.
If you have any audit-related questions, please contact the following email: Regulatory@A2A-AllianceRx.com.
RA/QA Artwork and Print Compliance (ARTPRF-#)
RA/QA Artwork and Print Compliance Electronic Submission Link
A2A Regulatory and Quality conducts thorough reviews and QA/RA Approval for each Print Component including Labels, Cartons, Patient Insert's, etc... to improve compliance and regulatory controls. The RA/QA Artwork and Print Compliance Submission helps to manage risks associated with product quality, safety, and efficacy, ensuring that the supplied pharmaceuticals for each Lot meet the appropriate cGMP (Current Good Manufacturing Practices) standards and FDA CFR Print and Labeling Requirements.
If you have any audit-related questions, please contact the following email: Regulatory@A2A-AllianceRx.com.