Pre-Authorization

Assessment and preparation services prior to initiating the formal authorization and import process, with the aim of reducing overall costs and required timelines.
Company
Scope of Services
• On-site visit to the company and production line and facilities to review operational processes against approved documentation,

• Assessment of the company’s quality management system in accordance with ISO 13485 and GMP principles,

• Review and organization of the company’s regulatory documentation and declarations in alignment with the requirements of the Iranian Ministry of Health, with a focus on completeness, consistency, traceability, and document version control, including identification of regulatory gaps.