REGULATORY AFFAIRS

In Laos, regulatory affairs are generally understood by many as the process of registering products with the relevant authority in which an application is lodged, reviewed, and the license is issued. This process, however, is only a small part of the whole regulatory affairs procedures.

We, together with our partners, want to apply the universal discipline not only for paperwork process, but for comprehensive consultation that cover both the technical and non-technical aspects of regulatory affairs to make sure that the registered products are safe and effective when used as advertised.

We want to help companies, especially foreign owned, with little or no presence in the country to understand local regulations and timelines before deciding to enter the Lao market.

What We Offer
• Regulatory consulting
• Regulatory roadmap for market entrance
• Product registration and license management
• Dossier preparation and regulatory submissions
• Label and promotional material review
• Quality management system compliance
• Product License Holders (PLH)
• Pharmacovigilance (PV)
• Assist with due diligence activities for investors/licensees