Hanny Nelis, BSc.

Hanny Nelis started in 1980 as Clinical Laboratory technician. As head technician in Blood Bank Leiden she had her first experiences with GMP. From there Hanny joined Xendo in 1993. Since 2007 Hanny is the manager of the competence center Healthcare that primarily focuses on healthcare organizations like hospital pharmacies, laboratories and blood banks. Hanny is accustomed to work in this environment that needs a specific approach due to the relative small organizations, diverse services and products and limited budgets.
Hanny has a lot of experience with the implementation of quality systems, like ISO, GMP and GMP-z. This includes performing audits, base line inspections, hands-on assistance with generating procedures, formulating policies, giving training, etc. Since the mid-90’s the validation of automated systems with GAMP has become one of her main topics.

Mieke van der Meulen, MSc, pharmacist

Mieke van der Meulen graduated as a pharmacist in 1989 and started her professional career in the pharmaceutical industry. Mieke started as manager Regulatory Affairs but switched to Quality Control and Quality Assurance a few years later. At that time she also took on responsibilities as Qualified Person. She joined Xendo in 2004 as senior consultant and also supervises a group of enthusiastic professionals who have Quality Assurance as their main line of action.
Mieke’s expertise focuses mainly on GMP and GDP regulations, development and maintenance of quality systems, auditing, GMP and GDP training. Furthermore, she is employed on a regular basis as Qualfied Person (marketed products and clinical trial material) and as Responsible Person on wholesale dealer’s licenses.

Rudolf Kikkert, BSc

Rudolf Kikkert has a Bachelor degree analytical chemistry background. He has fulfilled since 1982 several functions within various pharmaceutical companies, latest as manager QC. In January 2006 Rudolf has joined Xendo. He fulfills the function of Senior Consultant and Competence Manager “Quality Control Laboratories”. Besides extensive experience within quality control laboratories, he has significant experience in Quality Assurance, hospital pharmacies, production, logistics and research. Rudolf has an affinity for (ad-interim) management and project management, but also technical projects on content are performed regularity. Rudolf is able to execute thorough problem analyses, resulting in a pragmatic project approach, customized to the client's needs.

Marc Klinkhamer, MSc, PhD

Marc Klinkhamer has a scientific education in chemistry that was followed by a PhD in medicines. He then switched from the academic world to industry and worked in the pharmaceutical, medical device and IVD industry in position validation, QA, regulatory affairs, manufacturing, logistics and business development.
From the year 2000 Marc joined Xendo where he finds solutions on issues with respect to quality management systems issues, such as ISO9001 & 13485, the FDA QSR and the Canadian CMDCAS. Additional services are offered by his team on regulatory and associated topics. From wound dressings to implants, from IVD to active medical device, all sorts and kinds of devices were brought to the market by Xendo.