GxP audits & gap assessment
Amarant supports individual client needs in finding the most effective solutions to meet regulatory requirements, reach their goals and improve quality. Our expertise includes GxP compliance, advising on operational, managing interactions with regulatory agencies, and preparation and evaluation of SOPs, technical documents to comply with regulatory requirements.
Services We Offer
- High-level strategic consulting
- Qualification & validation services including GxP validation process, facility validation, equipment validation, other qualification & validation requirements
- Inspection readiness & support
- EMA/MHRA/FDA/TGA/WHO etc. pre-audits, support and compliance
- Systematic GMP review
- QA & compliance services including Documentation compliance, CAPA, Change controls, Deviations, archival & regulatory information management
- GxP audits & gap assessment
- Quality Management System including SOP Authoring and Reviews
* Good Practices (GxP)
- Good Clinical Practices (GCP).
- Good Laboratory Practices / Good Quality Control Laboratory Practices (GLP).
- Good Manufacturing Practices (GMP).
- Good Agricultural and Collection practices (GACP).
- Good Distribution Practices (GDP).
- Good Pharmacovigilance Practices (GvP)