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.