Our Strength

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"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.

Operative topics:

  • 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
  • Preparationfor Authority Inspections (European and US-FDA; in cooperation with QuaSyCon GmbH, see PARTNERS)
  • Validation and Qualification, Concepts and Documentation, Training and Guidance

Strategic topics:

  • 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, Tax Advisors, Public Accountants, see PARTNERS)

  • Co-ordinated technical and legal services
  • Contract development in close co-operation between technical and legal teams