"Experience and special know-how"
WS Partners can offer dedicated industrial know-how in peptide chemistry, recombinant protein manufacturing Quality Assurance (GMP) and project management.
- Drug Development: implementation of optimized routes for product development with respect to time and costs
- Project Management: set-up and implementation of development plans / hands-on supervision of complex projects / CMC Management
- Selection and Qualification of CMOs: we help our clients to identify CMOs for Drug Substance(s), Drug Product(s) and logistics services / drug supply. We also support our clients on Tech Transfer.
- Audits: Performance of GMP Audits
- Creation and Implementation of GMP – compliant QA Systems (including SOPs, training etc.)
- Documentation and support for the preparation of the relevant dossiers (e.g. IBs, IMPDs)
- Development of GMP – Compliant Production Processes
- Preparation for Authority Inspections (European and US-FDA; in cooperation with QuaSyCon GmbH, see PARTNERS)
- Validation and Qualification, Concepts and Documentation, Training and Guidance
- Business Development: Partnering, Deal- making, Due Diligences etc.
- Start-up Management
Special CMC fields:
- Peptide Chemistry (Solid Phase, Solution Chemistry etc.)
- Protein Chemistry
- PEGylation techniques
- Small Molecules
Technical Contract Services
(in cooperation with legal contract services of Weitnauer Attorneys see PARTNERS)
- Co-ordinated technical and legal services
- Contract development in close co-operation between technical and legal teams