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WS Partners can offer dedicated industrial know-how in biotechnology, life science, pharmaceutical and chemical business

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
  Audits: Performance of GMP Audits
  Creation and Implementation of GMP – compliant QA Systems
(including SOPs, MBRs 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
Strategic topics:
  Business Development: Partnering, Deal-making, Due Diligences etc.
  Patent Analyses and Patent Strategies
  Start-up Management
Special CMC fields:
  Peptide Chemistry (Solid Phase, Solution Chemistry etc.)
  Protein Chemistry
  PEGylation techniques
  Small Molecules
  Blood, blood components and anticoagulants
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

 

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