How Do We Do It?
Multi-sourced pipeline: SingEval leverages its global network in the search for potential healthcare products.
Commercial selection: use internal resource to research and conclude on Asian major country commercial development opportunities. This includes discussions with Asian KOLs and market research.
Portfolio selection: use internal resource with many years of experience of portfolio management to select opportunities which have a higher probability of meeting ROI targets. We have a sophisticated, dynamic tool incorporating different sales curves, payments to product originators, development costs, ROI and timing to enable product investment decisions for internal decision making and meeting investor expectations.
Asian development plan: use internal resource (supplemented on occasion by external specialists) to review existing North American and/or European databases and create development and regulatory plans.
Financing: create funding request documents for external funding and seek and obtain that funding. Our investors become part of the decision team to in-license a product.
Manage Asian development: use local CROs to create clinical trial supplies, conduct and report studies as well as alliance partners to:
- Deliver pharmacovigilance reporting
- Create study reports
- Provide a US-based secure central documentation file.
Regulatory Affairs : use internal specialized Regulatory Affairs resource Regaff to create marketing approval regulatory dossiers, negotiate with health authorities and gain approvals in each Asian country. Licenses will be held by SingEval owned companies in each country, nominated agents or the strategic partner company.
Product manufacture: arrange the manufacture of the product in a company with up to date GMP approved by US FDA or EU EMEA facility.
Commercialize: the product through an alliance partner.
Resourcing
We have experienced leaders.
We want to have a low fixed cost base as a part of our culture.
We are not experts in everything and access knowledge through extensive people contacts gained over many years of working in global development.
For greatest flexibility, we outsource most operational aspects of clinical trials.
We utililize RegAff , a wholly owned SingEval company, for all our regulatory affairs activities and benefit from their leveraging of expertise and managing of resource peaks.
We resource commercialization of products with no fixed costs through Asian local company Sales and Marketing partners.
SingEval operations are managed by a Singapore based COO and with Singapore-based legal and accounting support.