Regulatory / Quality
One of the most demanding aspects is working with the various regulatory agencies. Ensuring regulatory compliance is essential to the success and growth of a brand. Companies that lack an in-depth understanding of the regulatory framework could be missing out on important market opportunities. Submitting regulatory paperwork that is accurate and meets submission timelines is critical. And the more products there are to maintain, the more markets there are that a company must keep abreast of and the more sense it makes to outsource. Our knowledgeable team will guide you through the regulations so you can gain market access quickly, successfully, and with confidence.
Our team provide an intimate knowledge of requirements in different markets and can help chart the optimal path for you. We provide practical interpretation and support implementation of diverse regulatory guidance all around the world, including in new high-potential markets such as China.
We prepare documents for submission and interact with regulatory agencies on behalf of clients.
Our services can include:
- Investigational submission management
- Regulatory dossier compilation, publishing and dispatch
- Investigational submissions and lifecycle management
- Market authorization submissions and lifecycle maintenance
- Post-approval lifecycle maintenance
- Report compilation and publishing and archiving
- Regulatory Information Management – data entry, data cleansing, data migration
- Content creation and document services