컨설팅내용
- Regulatory Quality Compliance.
- Regulatory Affairs including product approvals and establishment of the companies (sanitary operational license and authorization).
- Post-marketing surveillance (mandatory and voluntary notifications | treatement of adverse events claims)
- Regulatory strategy.
- Good Manufacturing Practices certification (planning, prepare, audits).
- Regulatory support on import process.
- Change management with uation of regulatory impact.
- Risk management.
- Due diligence for acquisitions.