Expert Guidance Tailored for You
HARBYNE : Expertise in Regulated Manufacturing Environments
HARBYNE consulting specialises in delivering practical, cost-effective solutions in highly regulated industries.
Our focus on value and results positions us as a trusted partner to organisations navigating complex compliance and operational challenges.
HARBYNE offers a broad and comprehensive range of GMP and ISO consulting services to manufacturers, distributors, and sponsors across the Asia-Pacific region as well as being a trusted partner to pragmatically assess and improve your business risks and systems.
We work with clients in diverse sectors, including medical devices, pharmaceuticals, biologicals, cosmetics, medicinal cannabis and alternative therapies.
We bring expertise, insight and an experienced pragmatic approach to help your business achieve compliance, efficiency and a sustainable quality competitive advantage.
Audit
Experienced at independent internal audit, vendor audit and assessment and development of risk based audit strategies. We are here to help you meet your compliance responsibilities.
Risk Management
ISO 14971, ICH Q9, ISO 31000 compliance or just the development and roll out of a simple business risk based management system - we have you covered.
QMS & Digitalisation
From QMS design, implementation and review though to digital solution identification and implementation HARBYNE has the experience to assist you.
Operational Review
Want to better understand your operational and supply chain risks and bottlenecks? We are here to help with a pragmatic full or focused operational review with clear outcomes and actionable improvements.
Regulatory Inspection
With significant experience of dealing with all major global regulatory agencies covering FDA, Europe and Australia we can assist with your audit preparation, hosting and dealing with any indentified non-conformances.
Consultancy Time
If it’s simple advice you need then please go ahead and contact us for a confidential 1:1 conversation.