Quality and Compliance Services
ATL offers a full range of Compliance and Quality services to help your firm maintain a GMP-compliant company profile. We will assign highly qualified and experienced individuals from a network of industry experts to address your Compliance and Quality projects. Helping your firm stay in a steady state of compliance by consistently adhering to established procedures and standards is our goal. Periodic audits by our industry team will help verify site compliance and enable you to address issues before significant problems arise.
- Quality system development
- FDA-483, warning letter and consent decree remediation plans
- On-site assistance during FDA inspections
- Drug product recall support
- Strategic planning for FDA facility approval
- GMP and pre-approval inspection audits (FDA style “mock” inspections)
- CAPA management
- SOP development
- Training programs
- Audits of third-party companies to support facility and product acquisition plans