Insights. Integrity. Intelligence.
ABD Life Sciences is a Hong Kong head quartered cross-border life science advisory firm, bridging East and West, conducting business development for companies in biotech, biopharma, cell & gene therapy, pharma, vaccines, and medical technology including diagnostics.
With our experienced and well-versed network partners located around Asia and Europe we offer world class business intelligence, insights delivered with the highest level of integrity.
Partnering in the East – Partnering in the West; We provide you with support to reach your goals.
搭建東西方成功合作的橋梁
東洋での提携先も、西洋での提携先も：私たちは目的を達成するのに必要なサポートを、ご提供致します。
동양과의 파트너쉽, 서양과의 파트너쉽을 통해 우리는 당신의 회사가 장애물을 극복하고 성공하도록 지원할 것입니다.
Who we are & what we do
Since our inception in 2004 we have been operating semi-virtually. The services offered; advice, support, project lead & management, specialising in international business development with cross-cultural bridge building having one foot in the East and one foot in the West.
We cover nearly all areas of life sciences from R&D to commercialisation and beyond.
Finding and knowing your potential partner before we make it happen:
- Business development
- Business intelligence
- Search & evaluation
- Collaboration, partnership and M&A
- In- & out-licensing
- Audits & due diligence
- Gap analysis, value chain & business analysis
- IP and legal review
- Strategy development and strategic business planning
- Risk analysis and mitigation strategies
Pre-clinical and clinical development advisory & support:
- Search & evaluation, project management & coordination with KOLs and local/regional CROs in mainland China, Hong Kong, Taiwan, India, Korea, and Japan as well as in selected ASEAN countries to get products approved locally, regionally or globally.
- Understanding the differences and fulfilling local, regional or global regulatory requirement for market approval(s).
- Understanding local clinical practises and preferences by talking to KOLs, payers and patients.
- Clinical studies in Phase I / II / III, local and regional multi-centre studies as well as part of global trials.
- Development of strategic Japanese “Run-in” phase I/II studies for the fastest path for Japan to be included in a global pivotal study.
- Clinical development strategies by including Asian countries to global Pivotal studies for possible simultaneous approval in all major markets.
Advisory and Support with Regulatory Affairs, Procurement, Outsourcing and Biomanufacturing including Cell & Gene Therapies and Vaccines.
- Routes to regulatory approval in key Asian markets with local knowledge with respect to PMDA (Japan), MFDS (Korea), NMPA (China), HA (Hong Kong), FDA (Taiwan), HSA (Singapore) and FDA (Thailand).
- Supply Chain, finding and working with suppliers and CDMOs
- cGMP gap-analysis, audits and reviews of pharma/biopharma, Cell & Gene Therapy, Vaccines and Med Tech. according to PIC/S, EMA and USFDA
- Facility design, URS, lay-out, engineering, construction, with all steps from CD, BD, DD through FAT, SAT, IQ, OQ, PQ, PV, CV etc.
- Recommendations in bioprocess development, including scale-up, de-bottlenecking and scale-down for biosafety testing.
- Implementation of single-use technologies for bioprocessing, Cell & Gene therapies, and vaccines for Drug Substances as well as fill and finish for Drug Products.
- Market Assessment including:
- KOL and patient interviews
- Competitor analysis
- Price & Reimbursement
- Market Entry strategies, planning and activities
- Local representative office
- Sales channels
- Distributors & Agents
- Regional coordination
- Team building over time zones and different cultures