Welcome to Pietrek Associates

Who are we

Founded in 2009, Pietrek Associates is proud to be a leading, independently owned consultancy in
a sector increasingly populated by corporate conglomerates.

Pietrek Associates - About usPietrek Associates has a consultant network of more than 20 dedicated Health Science experts consisting of life-scientists, lawyer, pharmacists, physicians, and epidemiologists/ statistician who:

  • are experienced in drug development, marketing authorizations and post-approval surveillance
  • have worked in top 30 pharma companies, international CRO, and regulatory agencies
  • have individual experience in industry/ area of expertise of 10 to 30 years
  • have a proven track record of strategic and operational deliverables,
  • are contributors to innovation in drug regulations and transparency/ communication.

With a head office in the Mannheim area, Pietrek Associates has successfully delivered more than 200 projects. Our diverse client base comprises over 50 healthcare organizations, ranging from top pharma to biotech start-up companies as well as the associated investment community.

Why are we different

We understand that our clients are people, and we know that we can be successful by helping them to be successful – by listening, by advising and by being outstandingly good at what we do, wherever is needed, whenever it’s needed, whatever it takes.

What drives us

We are a team of passionate and experienced individuals wholly committed to helping our clients
to bring safe treatments to the world. We aim to employ only the very best people who share
with us our vision for:

"Excellence in our thinking, our client service and our delivery of outstanding expertise,
real enjoyment of our work, because we know we are making a difference,
dedication and professionalism in everything we do."

Managing Directors

Monika PietrekMonika Pietrek, MD, PhD, MSc

Over 28 years experience in clinical research and safety/ risk management in both pharmaceutical and CRO industries as well as in a regulatory agency. Broad range of therapeutic expertise, e.g. cardio-vascular disorders, CNS, gastroenterology, immunology, metabolic disorders, and oncology. Special interests include: clinical development strategies, quantitative benefit-risk evaluations, life-cycle risk management, pharmaco-epidemiology and organizational excellence.

Christina Vogt
Christina Vogt, M.A.

20 years of experience in both pharmaceutical and CRO industries, with demonstrated leadership in pre- and post-marketing pharmacovigilance and drug safety. Areas of interest include: creating processes and written procedures, quality and project management in safety operations, vendor selection and compliance monitoring as well as generation of periodic safety reports, safety data exchange agreements, and data reconciliation for MAA submission purposes.