SOLUTION-ORIENTED
Our focus is on quality as well as flexible, prompt, and solution-oriented service.Services
Regulatory Affairs for Pharmaceuticals
Consultation and support in the approval process as well as management of the regulatory product lifecycle
Quality Management
Consultation and support in the field of quality assurance (e.g., audits, inspections, GMP/GDP)
Support for obtaining establishment licenses for pharmaceutical companies
Expert assistance in quality management and creation/revision of quality management systems (QMS)
Assuming the role of the Qualified / Responsible Person for pharmaceutical companies
Compliance
Introduction to compliance and pharmaceutical advertising
Advertising material control considering applicable laws, EFPIA, Pharmaceutical Codex
Assessment of interactions with healthcare professionals (consulting, conferences, advisory boards, sample packs, etc.)
Evaluation of financial support for events organized by third parties and for healthcare professionals/patient organizations
Pharmacovigilance
Assuming the role of the Local Responsible Person for Pharmacovigilance
Receipt of adverse event reports and follow-up including internal forwarding and reporting to Swissmedic
Submission of RMPs, PSURs, and signal detections to Swissmedic
Product-specific research of current local literature and foreign regulatory authorities’ websites.
Pharmacovigilance training
Pharmaceutical Logistics
Planning and conceptualization for goods flow, transportation, spaces, and facilities, warehousing
GDP training
Medical Devices
Classification assessment, verification of marketability
Independent consulting firm
Led by Anne-Käthi HauserPortrait
Pharma Distribution Services GmbH is an independent Swiss consulting firm. The company is led by Anne-Käthi Hauser.
We offer our clients customized solutions for their needs. As your partner, you can rely on personalized support. If necessary, we are also happy to perform work on-site at the client’s location.
Our focus is on quality as well as flexible, prompt, and solution-oriented service.
Tamara Binzegger
Engineer in Biotechnology from the University of Applied Sciences Wädenswil (ZHAW), with extensive experience in quality assurance, as a Qualified / Responsible Person, in Regulatory Affairs, and advertising compliance. Acting as the Qualified / Responsible Person at Pharma Distribution Services GmbH since 2022.
