Our Services
Quality Systems and Compliance
We advise on cGMP compliance matters for APIs, drugs (small and large molecules) and medical devices. With decades of QA/QC experience, we provide practical help with facing audits and inspections. If you are seeking support for compliance assessment, come talk to us.
Sterility Assurance
The sterility assurance program is the framework for upholding the sterile label claim for drugs and devices. It is built upon knowledge and experience in microbiology, biocontamination control, aseptic processing and sterilization. We provide a range of domain expertise and services for your need: strategy development, procedural development, training, auditing, risk assessment, failure investigation and more.
Laboratory Compliance
Our knowledge and experience in cGMP laboratory management stood us in good stead to support your goal of achieving and maintaining laboratory compliance. This includes analytical method development and validation, laboratory systems creation and enhancement, gap assessments and resolving laboratory issues (e.g. data integrity issues). We can customize an appropriate solution for your needs.
Validation
We combine industry experience and resource networks to bring the right expertise to implementing laboratory systems validation, sterilization process development and sterilization validation. If you require support with equipment qualification, life cycle validation of related computer systems, risk assessments, implementation and periodic review or something more, we can customize a solution for you.
Sterilization
From the selection of a suitable sterilization method to sterilization development, validation and routine control, we provide the strategy and resource for establishing the sterilization of container closures and medical devices. We also help with sterilization support activities like bioburden testing, test of sterility, BI or PCD development, dosimeter development and supplier qualification.
Microbiology and Biocontamination Control
Bioburden testing, endotoxin testing, sterility testing and environmental monitoring are integral parts of drugs and devices manufacturing and quality control. Be it strategy development, method development or program management, we can help. We also support the sourcing and qualification of contract testing services, including supplier audits.
When quality compliance keeps you from entering the drug and device markets, we can help!
Contact us 
Our Service Focus
Asia for the World
Based in Asia and connected to global expertise on GMP matters, we help companies in Asia to serve the healthcare needs of the world. We are excited about growing with researchers, start-ups and small-and-medium enterprises to achieve this glorious goal.
Conquer with Collaboration
We work with subject matter experts, research institutions and government agencies to identify domain expertise for tackling complex problems.
Customizing for You
Every company is unique and we celebrate your singularity by working out what suits your organizational culture, your systems and your immediate need.