Services

Regulatory Affairs Consulting Services:

Given our experiance and expertise in sucessfully registering medical products in the Kingdom of Cambodia, we are always ready to connect with respectable parties and provide support in these tasks. 
All regulatory services requests are carefully evaluated and addressed with a high level of responsibility and dedication by our team of experts. 
Our team is ready to provide full support and guidance throughout the regulatory system and process to assure smooth and timely product registration in the Kingdom of Cambodia.

License securing

We will provide all that is necessary for sucessfully securing license for products, including: 

Pharmaceutical Products

Dieatary/Health Supplements

Traditional
Medicine

Cosmetic
Products

Medical
devices

More important besides anything else our regulatory team will always strives to uphold quality, safety and efficacy of healthcare products to be introduced in the Kingdom of Cambodia.

Medicinal Product Registration

We can assist in preparing and reviewing of technical dossiers for submission and assist in handling enquiries from the regulatory authorities. 

We can help you in reviewing Chemistry Manufacturing Clinical (CMC) data for use in product registration,
– preparing Common Technical Dossier in the necessary format (ICH, ASEAN CTD), 
NDA, GDA, MAV (New Drug Application, Generics Drug Application, Major Variation Application). 

Regulations related to Pharmaceutical products in Philippines continue to pose a major challenge for the global generic industry. In such situation – a sound regulatory strategy is key to get the products registered and opens ways for new business alliances. 

Any sound regulatory strategy stands on effective planning and implementation. Regulatory Operations by way of New Filings, dossier compilations or variations, running procedures on client’s behalf is an influential support for startups and established businesses as well. 

Ambica provides regulatory services required throughout the product life cycle i.e. from Production to Launch to Post Launch activities. 

Ambica helps pharmaceutical companies to manage their regulatory affairs assignments by dossier compilation, regulatory filings & approvals, post approval renewal management, regulatory compliance and regulatory support for marketed products. 


Triple I Consulting is willing to guide you through the product registration process, and in preparing the legal requirements to ensure the safety and efficacy of your products. Our Regulatory Affairs Department is able to provide proper assistance in the preparation of documents to minimize certain incomplete requirements for regulatory approvals and to avoid rejection of registration or licensing.