Services
Know-How, From Product Development to Market Entry
From product development and technology transfer to registration and market entry — services drawn from our own record in biological manufacturing and export.
01 · Biological Product R&D
From Antigen to Finished Product
- Contract development of biological products
- Antigen design and formulation development
- Analytical method development and potency testing
- Product and process validation support
- Scientific & technical consulting
Backed by Practical Experience
RasFab® Heptavalent Antivenom
The full development of RasFab® over six years of field, laboratory and technical research is the foundation of the R&D capability we now put at our partners' disposal.
02 · Technology Development & Transfer
From Know-How to Industrial Production
- Compilation and transfer of the know-how package
- Production process design
- Manufacturing know-how implementation
- Technical consulting
Process Design
Design, development and scale-up of industrial production processes.
Know-How Transfer
Manufacturing know-how implementation.
03 · Regulatory Affairs and Product Registration
Dossiers That Stand Up to Review
- Support for product registration and obtaining marketing authorisation
- Compilation of quality and CMC documentation
- Dossier compilation and documentation gap assessment
- Responses to regulatory authority queries and deficiency letters
- Drafting and review of labelling and product information
Practical Experience in International Markets
Regulatory Experience in Seven Markets
Dossier preparation, technical documentation aligned with the requirements of the regulatory authority in each destination country, follow-through to marketing authorisation, and support for market entry.
04 · International Business
Market Access, Managed
- Market access strategy
- Export operations planning and management
- Regional distribution network development
- Trade partner identification and development
- Support for tender participation and institutional supply
Export Management
Export planning and operations.
Distribution Network Development
Identifying and developing regional trade partners and distribution networks.