PharmOut

PharmOut is a leading consultancy firm specializing in GMP (Good Manufacturing Practice) for medical devices and pharmaceuticals. Established in 2006 in Melbourne, Australia, PharmOut has become a major player in the Asia Pacific region, offering comprehensive services to manufacturers and product distributors.

PharmOut's services cater to a wide range of industries, including pharmaceuticals, medical devices, veterinary, and more. They support industry and regulatory agencies with their deep expertise in GMP compliance.

Key Services:

• Auditing: On-site or remote audits to identify compliance gaps in GCP, GMP, or GLP standards.
• Consulting: Expertise in medical device and pharmaceutical quality systems, ensuring compliance with standards like ISO 13485.
• Contract Staff: Access to QA and GMP contractors, including architects, engineers, and scientists.
• Design and Engineering: From feasibility to detailed design, ensuring facilities meet GMP regulations.
• Temperature Mapping: Comprehensive services for controlled temperature storage compliance.
• Project Management: Guidance on GMP project planning and execution.
• Technical Writing: GMP documentation with a focus on plain language and regulatory compliance.