HAUSHEER BIOMED, LLC.
Austin (Texas, USA) Shanghai (China)
Index
Services
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en
Index
Services
Partners
About us
Contact us
EN
Product Development
Hausheer Biomed, LLC.
Pre-Clinical Translational Medicine, GAP& competitive analysis, solutions.
Non-Clinical/Clinical Pharmacology & Safety Analysis; dose & escalation justification, dose/schedule optimization justification.
Risk Management: Pre-Clinical, Clinical, Pharmacology, Safety, Efficacy& Regulatory Acceptance.
Clinical Trial Development strategy & planning, Trial Design, Endpoints, Protocol Development
NDA/BLA medical review of safety & efficacy, CMC review, pharmacology review
Clinical Operations Management (CRO & Vendor Selection, Contracting & Management)
Commercial Clinical Development and Strategy implementation.
FDA, NMPA, EMA, PMDA, and other regulatory interactions.
Vendor/CRO, Site, investigator selection, bid defense, and contracting.
Preclinical translational development support PIND/IND
PIND/IND medical, regulatory, quality review & applications, meetings
CMC Safety Assessments
ICH GCP Compliance assessments & training
Form external expert team to work with in-house team CEO/R&D
Due diligence for financing, valuation, acquisition, mergers & licensing
Strategy & Commercialization
Hausheer Biomed, LLC.
Go-to-Market Strategy Development (China &APAC)
Brand Strategy Development
Forecasting Model
Product Launch Planning
Early Access Solution in US, EU, APAC and China
Form external experts to work with in –house team on Medical Marketing
Opportunity and Risk Assessment and Mapping
Business Development
Hausheer Biomed, LLC.
Partnering & Deal- making
Pharma & Biotech Valuation
Due Diligence
Asset Sourcing