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Regulatory affairs & quality assurance

Two decades of Asia-Pacific regulatory expertise — documentation, testing, audits and registration approval, so your product reaches shelf compliant and on time.

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Compliance handled, so you can focus on your brand

Regional regulatory complexity, managed end-to-end.

Every Asia-Pacific market has its own registration process, labelling rules and testing requirements. Our regulatory affairs and QA team manages the detail — dossier compilation, stability and analytical testing, facility audits and registration submissions — so products move to market without compliance surprises.

  • Dossier compilation and submission across APAC markets.
  • Stability and analytical testing to local requirements.
  • Facility and supplier audits, and ongoing compliance monitoring.

From documentation to approval

A structured path through regional compliance.

01

Documentation & dossier prep

Compiling the technical file each target market's regulator requires.

02

Testing & stability

Analytical and stability testing to confirm the product performs as specified.

03

Registration submission

Managing submission and queries with the relevant regulatory bodies.

04

Ongoing compliance

Monitoring regulatory change and maintaining registration status.

Strict adherence to Quality Assurance procedures

Every batch we supply is tested at factory and independent labs according to regulatory requirements, GMP standards and any custom requirements. Test results for each batch are compiled into Certificates of Analysis and typically include Physical Testing, Assay Testing, Microbiological Testing and Heavy Metal Testing to ensure compliance against Finished Product Specifications. We also conduct pre-launch and post-launch Stability Testing, including Zone IVb, to justify product shelf life. We welcome factory audits by independent auditing companies and brand QA teams.

Our global manufacturing base is underpinned by a range of certifications and standards.
cGMP
TGA Approved
FDA
NPRA Malaysia
ISO 13485:2016
IFS
Halal

Need regulatory support for a new market?

Tell us your product and target country — we'll map the registration pathway.