Quality Assurance & Compliance
Atheln’s QA team can supplement your in-house QA team or become your QA team
When developing pharmaceutical products, the concept of Quality Assurance (QA) needs to be embraced from the very beginning. For regulatory compliance, any product targeted for human administration shall meet all quality, efficacy and safety requirements at any stage of development. The early establishment of a QA culture enables seamless transition from one stage of development to the next as requirements increase.
Atheln has an industry-seasoned team of quality experts with extensive global experience who can supplement your in-house team or become your QA team.
Atheln’s Quality Assurance & Compliance services include:
- Conducting gap analysis of client and/or CMO, CRO practices
- Designing phase-appropriate quality systems
- Writing SOPs suited to the company structure
- Providing training in all aspects of QA and compliance, including global GxPs
- Auditing CMOs, CROs and critical suppliers in the US and worldwide to ensure QA practices comply with the requirements of the stage of development as applicable
- Reviewing / improving Quality Agreements in support of GxP activities
- Maintaining your Quality System, including daily operations as needed
Control documents review (virtual): MBRs (Master Batch records) / EBRs (Executed Batch records); raw materials and finished product specifications, stability protocols and reports, equipment qualification and process validation reports, validation protocols and reports, deviations and OOS investigations, shipping documentation, product complaint analysis, annual product reviews, etc.
- Conducting audits “For Cause” when compliance problems arise and assist on remediation management
