A&O Pharma GmbH

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