Szolgáltatások

GXP Audits & lnspections: Full compliance with EU standards far Good Manufacturing, Distribution, and Laboratory Practices.

European Affiliate Office Setup: Establish a seamless local presence far your pharmaceutical operations.
GDP-Compliant Transport & Warehousing: Secure and compliant logistical solutions far pharmaceutical
storage and distribution.

Import, Packaging, and Certification: End-to-end management of product import, packaging, labeling,
batch testing, and EU certification.

Regulatory Affairs: Complete submission management, eCTD support, readability testing, and
multilingual translation services.

Pharmacovigilance: EU QPPV and local pharmacovigilance services to ensure ongoing safety
monitoring.

Quality Assurance: Comprehensive support with Responsible Person (RP) and Qualified Person (QP)
services, ensuring product quality and safety.