Member overview

A&O Pharmadienstleistungen

Key figures / Profile

  • Qualified Person according to § 14 AMG
  • Dr. Mundszinger has more than than ten years experience in pharmaceutical analytics, pharmaceutical manufacturing and compiling of cmc documents for IMPDs and Manufacturing authorisations
  • Consulting company founded in beginning of 2019
  • Own Manufacturing authorisation and cGMP certified by Regierungspräsidium Tübingen

We offer

  • QP-Service, e.g. Release of IMPs or Market release of Pharmaceutical products,
    Batch record review, Assesement of Deviations, Risk Assessements, etc.
  • Execution of GMP- or GLP-Audits (Supplier Qualification: APIs, Excipients, Packaging materials; Contract manufacturers, Contract laboratories)
  • Consulting and Support related to cGMP, ISO 13485, MDR (Medical device regulation) and IVDR (In-vitro-Diagnostica regulation)
  • Support for Inspections by Authorities
  • Establishment and Optimization Pharmaceutical Quality System
  • Dossier Writing (CMC-Part of Marketing Authorisation Dossiers & IMPDs)
  • Interimsmanagement Qualitäty Assurance and Quality Control
  • Support and Documentation of Validations and Qualifications

Contact

Please contact us for further information:

Dr. Olaf Mundszinger

o.mundszinger@aopharma.de