No matter the size of your business, whether you have a development team or experience, when there is a good idea of your healthcare products, we can always assist you to bring that idea to the reality.
With the knowledge and experience of healthcare products and the science behind that, the in-depth understanding of the local regulatory requirements, and the extensive connection with the industry, we can offer professional scientific and regulatory support to you.
Chemistry, Manufacturing & Control
- Facilitation and negotiation with GMP licensed contract manufacturing organisations (CMOs) to formulate and manufacture the products
- Facilitation and negotiation with contract laboratories for testing (e.g. test method development and method validation, stability study, comparative dissolution test, etc.)
- Overseeing quality requirements, and building up quality and manufacturing dossiers
- Gap analysis of overseas dossiers and supplementary development to fulfil local registration requirements
Efficacy & Safety
- Development and substantiation of therapeutic claims and indictions
- Facilitation and negotiation with contract research organisations (CROs) for clinical studies
- Product repositioning
- Literature search and development of scientific or technical arguments
- Development of efficacy and safety dossiers