Quality
Phase-Appropriate, Science- and Risk-Based Approach to Quality and Compliance:
Syner-G BioPharma Group’s comprehensive team of highly experienced Quality and Compliance experts can assist life science companies across all aspects of cGxP including preclinical, clinical, and cGMP. Regulatory compliance, including adherence to cGMP requirements, is necessary to ensure safety and efficacy of pharmaceutical supplies. It is also a key component for successful product development, regulatory approval, and maintenance of an uninterrupted supply chain. We apply the same scientific, risked-based and phase-appropriate approach to quality compliance that’s been proven effective in our technical and regulatory solutions. We strive to match the solution to each client’s particular needs rather than taking a cookie-cutter approach.
Syner-G’s Quality and Compliance Team Provides:
- QMS development and implementation
- GMP investigations and deviation reports
- Product complaints and product recalls
- QA audits (GLP, GMP, and GCP)
– GMP, GLP, and GCP audits of contract service providers - Development of Standard Operating Procedures (SOPs)
- GxP documentation review
- Data integrity programs
- GMP training
- PAI-readiness assessment/support
- Computer System Validation (CSV)
- IT project management
- GxP IT remediation
- Periodic review of GxP systems as a service
Headquarters
100 Pennsylvania Avenue, Suite 310
Framingham, MA 01701
Contact Us
508.460.9700
info@synergbiopharma.com