Bivalin is a consulting service providing analytical diligence of biomedical/ pharmaceutical therapeutic business models and technologies within Australia, the USA, Europe, Mainland China as well as South East Asia including Hong Kong. These services have been provided to venture capital firms, angel investors, investment consultants, government agencies, and pharmaceutical and biotechnology enterprises. They have been provided in the domains of both human and veterinary medicine and cover the following areas of expertise:
- Business, market entry, clinical and corporate strategy,
- Preclinical research and clinical trial management,
- Company and project valuations (DCF, risk adjusted NPV, Monte Carlo Simulations, Real Options),
- Technical, financial, M&A and IP target diligence,
- IP defence, capture and licensing,
- The negotiation of regulatory landscapes, including: FDA, EMA, HSA and TGA submissions, and including orphan submissions,
- GLP, GMP drug substance and product development and management,
- Drug reformulation and repurposing strategies and
- Infrastructure development
Although not limiting, speciality fields include: respiratory, hepatic, pancreatic, haematopoietic, articulation (e.g. for arthritis), neural and cardiac systems; and in the fields of cancer and stem cell therapeutics.
See Capabilities