Regulatory Advice Service South East Asia

Indochina Labs has dedicated resources which enable us to provide regulatory solutions to support our clients’ product development programs. We can also provide on-going regulatory support once your product is registered.

Our broad functional and therapeutic area expertise enables us to provide specialised inputs to clients according to their needs. We have substantial experience in the US and Vietnam.

• Regulatory Strategy input to the Product Development Plan
• Preparation of Clinical Trial & Ethics Committee applications and on-going support for trials including Safety Reporting
• Preparation of Product Registration applications, Drug Masterfiles and Post –approval regulatory submissions (renewals, variations, defence documentation)
• Project Management and co-ordination of registration applications including interfacing with Regulatory Authorities on behalf of clients.
• Provision of Clinical, Quality and Safety (CQS) Expert Reports and Summaries