Quality Management & Compliance Services

We provide comprehensive pharmaceutical quality management compliance consulting to help companies meet Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) standards. Our quality assurance and quality control services include:

• Quality system and SOP development aligned with NMPA and Asia-Pacific regulatory requirements
• GxP audits, gap analysis, and inspection readiness
• Vendor qualification and supply chain oversight to ensure manufacturing processes meet industry standards
• Ingredient compliance verification and regulatory documentation checks
• Pre-approval inspection support, corrective action planning, and continuous improvement initiatives

We provide quality management and compliance services for medical devices and IVDs in China, Hong Kong, Taiwan, and the six ASEAN countries we cover: Singapore, Malaysia, Thailand, Vietnam, Indonesia, and the Philippines. Each market has unique regulatory requirements, and our team ensures your quality management system meets both local rules and international quality standards.

In China, the NMPA demands compliance beyond ISO 13485, incorporating Chinese GMP. Hong Kong follows MDACS, with a focus on classification, safety, and quality control. Taiwan’s TFDA requires harmonisation with ISO 13485 plus local compliance requirements. Across ASEAN, each regulator, from Singapore’s HSA to the Philippines’ FDA, has distinct industry standards and inspection protocols.

We help you navigate them all with:

• Gap analysis and adaptation for multi-market compliance
• SOP, work instruction, and record optimisation
• Supplier qualification, audit programs, and CAPA planning to improve quality
• Inspection preparation and on-site support to avoid non-compliance
• Post-market surveillance, vigilance, and reporting tailored to each jurisdiction

Our approach unifies your global quality processes while tailoring to each market, so you meet quality expectations, safeguard market access, and deliver quality products customers trust.

We support foreign manufacturers throughout the entire Korean quasi-drug registration process, from initial feasibility assessment and classification through MFDS submission, Korean labeling, import coordination, and ongoing lifecycle compliance.

South Korea is one of Asia’s most advanced and highly regulated consumer healthcare markets, offering significant opportunities for overseas manufacturers of quasi-drugs, sanitary products, and hygiene-related healthcare products.

In Korea, quasi-drugs are regulated as a distinct product category separate from cosmetics and pharmaceuticals. These products typically include items with mild preventive, disinfecting, sanitary, oral care, or hygiene-related functions and are regulated by the Ministry of Food and Drug Safety (MFDS).

Our services include:

• Review of quality management systems and MFDS compliance requirements
• Support for manufacturing site, supplier, and product change management
• Review of specifications, test methods, and quality documentation
• Korean labeling, packaging, and advertising compliance review
• Support for post-market obligations, recalls, and safety communications
• Ongoing monitoring of MFDS regulatory updates and lifecycle compliance requirements

We deliver quality management and compliance services for cosmetics and ingredients in China and Taiwan, two highly regulated markets where strong quality management standards and precise compliance requirements are non-negotiable.

In China, the CSAR framework requires a quality management system aligned with NMPA Cosmetic GMP that goes beyond ISO 22716. That means strict quality control, traceability, and adherence to regulatory requirements for every product. We prepare you with mock audits, SOP localisation into Chinese, CAPA programs, and lifecycle monitoring to eliminate non compliance and protect your market position.

In Taiwan, TFDA regulations align with ISO 22716, the internationally recognised cosmetics GMP standard, which sets best practices for production, quality control, storage, and shipment. We implement quality systems that fully comply with ISO 22716 and local TFDA rules, ensuring product safety and robust quality assurance throughout your manufacturing processes.

Our services include:

• Gap analysis for NMPA and TFDA compliance
• SOP development, localisation, and integration into company's processes
• Supplier qualification and oversight to meet industry standards
• Pre-audit and inspection readiness with bilingual support
• CAPA follow-up for continual improvement

China's State Administration for Market Regulation (SAMR) enforces stringent quality control for supplements, functional foods, and FSMP. We support compliance by:

• Establishing or enhancing a quality management system for special foods in line with Chinese GMP to produce quality products
• Conducting gap assessments and documentation localisation
• Preparing for self-inspections and regulatory site visits
• Implementing product traceability, contamination prevention, and CAPA systems
• Ensuring regulatory alignment for labelling, claims, and shelf-life validation

Veterinary products face rigorous regulatory obligations for safety, efficacy, and quality in China. We assist with:

• QMS design and documentation control to meet company's operations objectives
• GMP audits and inspection readiness to prevent reputational damage
• Supplier oversight and raw material compliance verification with external partners
• Lifecycle quality monitoring and continual improvement programs

For industrial and consumer goods, especially where a China Manufacturer License (CML) or SELO compliance is required, we offer:

• Consultation workshops and regulatory briefings creating awareness of compliance requirements
• On-site and remote friendly audits with gap analysis and action plans
• QMS handbook review and adaptation to SELO management and control measures
• Documentation readiness checks for factory inspections to ensure compliance with all regulations.