What We Offer
Our Core Services
Tailored regulatory solutions designed to accelerate your market entry while ensuring full compliance with local and international standards.
01 — Registration
Medical Devices and Cosmetics Registration
Our seasoned in-house team streamlines complex regulatory requirements, offering a one-stop solution for document preparation, submission, follow-up, and approval. We significantly reduce approval timelines while ensuring full compliance and minimizing risks across multiple jurisdictions.
- Device classification and regulatory pathway analysis
- Complete dossier preparation (CSDT, technical files)
- Authority submission and liaison management
- Conformity assessment coordination
02 — Licensing
Authorized Representative Services
As your dedicated independent Authorized Representative, we serve as your trusted liaison with regulatory authorities. Our proactive approach and deep regulatory expertise ensure your interests are protected throughout the entire process. As an independent license holder, we provide you with the flexibility to work with different distributors.
- Independent AR/LAR services in Malaysia
- Full ownership of regulatory data and licenses
- Seamless distributor switching support
- Local regulatory authority communication
03 — Equipment
Medical Equipment and Cosmetic Compliance
Comprehensive medical equipment and cosmetics classification, certification, and conformity assessment services to meet local and international standards. We help manufacturers and distributors navigate complex compliance requirements with confidence and efficiency.
- Equipment classification and risk assessment
- Conformity assessment body coordination
- Quality management system development
- Technical documentation review and gap analysis
04 — Post-Market
Post-Market Surveillance
We assist with post-market incident reporting, including Field Safety Corrective Actions (FSCAs), mandatory problem reporting, and recalls. We monitor regulatory changes, manage reporting obligations, and implement updates, allowing you to focus on growing your business while maintaining full compliance.
- Vigilance reporting and incident management
- Field Safety Corrective Action (FSCA) coordination
- Regulatory change monitoring and impact analysis
- Product recall management and execution
05 — Distributor Support
Distributor Identification Support Services
Finding the right distributor is essential for successful market entry. Our team supports you in identifying suitable Malaysia-based distributors who are aligned with your product category, commercial goals, and regional distribution needs. We assist throughout the process, from distributor mapping to coordination and commercial discussions, helping you connect with the right local partners to support product distribution in Malaysia.
- Product-Specific Distributor Identification
- Distributor Coordination
- Distributor Assessment
- Distributor Management Support
- Contract Negotiation Support
06 — Consultancy
Regulatory Consultancy
Expert regulatory consultancy services to support your strategic decisions. From market entry feasibility studies to regulatory gap analyses, our specialists provide actionable insights tailored to your specific products and business goals.
- Market entry feasibility studies
- Regulatory strategy development
- Regulatory intelligence and updates
- Training and capability building
Not sure which service you need?
Our regulatory experts are ready to help you identify the right solution for your specific situation. Get a consultation today.
Schedule a Consultation