GXP-PHARMA SUPPORT A/S

GxP-Pharma Support A/S is a Danish consultancy firm offering various GXP consulting services to the pharmaceutical and biopharmaceutical industries as well as other organizations regulated by the Health Authority. Headquartered in Sorø, Denmark. Here are key aspects of the company:

• Products & Services: Specialized audit of suppliers and contract manufacturers including reporting, contract drafting, compliance checks, and upgrading GMDP quality systems with necessary documentation and reports.
• Products & Services: GDP support covering compliance checks of quality systems, implementation of risk assessment, deviation management, change control, management evaluation, and assistance from § 39 application to temperature mapping for new GDP businesses.
• Products & Services: Full implementation guidance for ISO 9001 or ISO 1705 including GAP analysis, audit, preparation of necessary documentation and registrations, and participation as an observer during accreditation audits.
• Products & Services: Tailored training courses for personnel based on daily tasks and current authority requirements to address internal company needs and regulatory mandates. GxP-Pharma Support A/S provides comprehensive quality assurance expertise ranging from GMP and GDP compliance to ISO certification, project management support, and specialized resource provision for release and pharmacovigilance.