ABOUT US
MaH are experts in the storage, distribution, labelling and packing of clinical trial materials in APAC and Global regions. Our GMP/GWP facility is designed to meet the needs of clinical trial sponsors, contract research organizations (CROs), and other vendors involved in the clinical trial supply chain.
Why Us?
Patients First
MaHPharma started with the goal to help patients around the world gain rapid access to clinical and commercial therapeutic treatments.
We understand the impact that supply chain shortages and limited access to quality medicines can have on patients.
We are focused on developing quality systems ensuring patients receive quality medicines with speed and efficiency to the market.
Quality Matters
We are seasoned quality professionals in all relevant regulatory guidelines including but not limited to, PIC/s, TGA, MHRA, NMPA, ICH, ISO, PDA and WHO.
Our quality management systems are based on over 20 years of experience working in the pharmaceutical regulated environment ensuring quality medicines are delivered right the first time.
Collaborative Spirit
We are solutions focused and teamwork is at the heart of our company culture.
Our dedicated industry professionals work with you to identify your service requirements.
MaHPharma will assign you an experienced project manager to look after your end-to-end needs.
Innovative Thinkers
We challenge the status quo and continuously seek opportunities for innovative ways of working.
We are LEAN centric and look at current and new technologies to make our client experience efficient eliminating waste from our systems.
We are committed to embracing change and proactively seeking opportunities for improvement.
MaH License & Compliance
-
TGA GMP Licence: Licence No. MI-2023-LI-09891-1
-
Secondary Packaging
-
Primary & Secondary Labelling
-
Release for Supply
-
-
NSW Wholesale & Distribution License: Licence No. WL2424
-
ISO-9001 Quality Management Certification
Meet Our Quality Leader
Matthew Bugg
Global Quality Director - Clinical Trials Depot Mgt
Matthew has over 20 years of experience in the pharmaceutical industry, starting in his family's community pharmacy before moving into hospital pharmacy and eventually transitioning into global pharmaceuticals. He has held leadership roles at major companies like GSK, Roche, AstraZeneca, and BeiGene, gaining extensive knowledge of regulatory guidelines, including PIC/s, TGA, MHRA, CFDA, ICH, ISO, PDA, and WHO.
Matthew holds a Pharmacy degree from Birkbeck University, London, and a Master’s in Pharmaceutical Technology and Quality Assurance from Leeds School of Healthcare, UK. His early career in hospital pharmacies included compounding IV chemotherapy for clinical studies, giving him firsthand insight into the positive impact of clinical trials, particularly in oncology medicine.
Meet Our Commercial
Leader
Huanyi Chen
Co-Founder & CEO
With a rich educational background from La Trobe University, Huanyi is the current CEO at MaH Clinical Trial Solutions. Her core competencies in supply chain management play a pivotal role in the delivery of clinical trial medicines. Her focus centers on relationship building and logistics management, ensuring excellence in the clinical supply chain processes, from packaging to global distribution.
At MaH, her team has successfully managed numerous clinical study depot projects, fostering robust vendor and supplier relationships that contribute to business development. The collaborative efforts at MaH resonate with the company's culture of quality and integrity, bringing diverse perspectives to the forefront of clinical trial solutions, and enhancing patient and sponsor experiences.
Common Questions
Can you provide tracking and reporting tools to keep us informed about the status of our trial supplies and shipments?
We will monitor and record all aspects of clinical trial product distribution and inventory status meticulously. We can furnish the client with comprehensive reports, including an inventory status report specifying the quantities received, dispatched, and currently stored.
What measures are in place to ensure the safety and security of clinical trial materials?
Our GMP-compliant warehouse prioritises the safety of clinical products. With 24/7 CCTV, security alarms, and continuous temperature monitoring, we ensure adherence to required conditions. Backup power supplies prevent interruptions during unexpected outages, guaranteeing stability for stored clinical materials.
What measures are in place to prevent product mix-ups or errors during the distribution process?
Every product will be carefully placed in its assigned storage area, accompanied by detailed information. This meticulous approach forms an integral aspect of our inventory management system, fostering improved traceability and mitigating the potential for errors.
How does the clinical trial supply chain function?
MaH offers a comprehensive array of services tailored to meet the specific requirements of our clients, including importation, manufacturing, labelling, production, storage, distribution, procurement, returns, destruction, reconciliation, project management, release for supply, and more.
Do you offer consulting services to help us navigate the regulatory requirements and logistics challenges unique to clinical trials?
We do provide consulting services tailored to address regulatory requirements, including TGA/GMP licensing. Our primary objective is to address any concerns related to logistics, especially those associated with the international importation of clinical trial products.
How can you reduce label waste?
We offer Just In Time (JIT) Labeling Services to meet our customers' needs for flexibility. This service can be seamlessly integrated into multi-territory distribution processes without affecting timelines. It is also ideal for late-stage customization of clinical materials when required.