About us

acora pharma GmbH was founded in 2000 by Dr. Martina Jaworek with the objective of offering holistic services relating to Drug Regulatory Affairs and Quality Control.

Our experts are qualified scientists or have completed vocational training as pharmaceutical technical assistants. Each of them has long-standing experience in the pharmaceutical industry (e.g. Regulatory Affairs, Regulatory Affairs CMC, Quality Assurance, Quality Control), consultancies or health authorities.

Dr. Martina Jaworek

Managing Director

1983 – 1988
Studied Pharmaceutics, Rheinische Friedrich-Wilhelms-University Bonn
06/1988
License to practice as Pharmacist
1988 – 1991
Doctorate, Eberhard Karls University Tübingen
02/1991
Graduated as Dr. rer. nat.
1991 – 1993
Schwarz Pharma AG - Quality Assurance Department (Monheim): Academic employee and later promoted to Group Manager
1993
Acquired expert knowledge as Qualified Person according to the EU Directive 2001/83/EC
1993 – 2000
Bayer AG, Consumer Care Division – International Regulatory Affairs Department (Leverkusen): Regulatory Affairs Manager and later promoted to Head of the Department
1995
Appointed as Pharmacist for Drug Information
2000
Founded acora pharma GmbH, Cologne

Dr. Stefanie Becker

Senior Regulatory Affairs Manager

1996 – 2001
Studied Biology, Rheinische Friedrich-Wilhelms-University Bonn
2002 – 2006
Doctorate, Rheinische Friedrich-Wilhelms-University Bonn
08/2006
Graduated as Dr. rer. nat.
2008 – 2012
neuraxpharm Arzneimittel GmbH (Langenfeld): Regulatory Affairs Manager
2013
Federal Institute for Drugs and Medical Devices (BfArM), Validation of Variations (Bonn): Academic employee
since 2014
acora pharma GmbH (Cologne): Senior Regulatory Affairs Manager

Ruth Bemelmanns

Senior Regulatory Affairs Manager

1986 – 1991
Education as Pharmaceutical Assistant and thereafter, Pharmaceutical Technical Assistant (Cologne)
1991 – 1994
Lücke GmbH – Laboratory (Aldenhoven): Pharmaceutical Technical Assistant
1994 – 2000
Studied Pharmacy, Heinrich Heine University Düsseldorf
03/2001
License to practice as Pharmacist
2000 – 2009
Schwarz BioSciences GmbH / UCB-Group – Regulatory Affairs CMC Department (Monheim): Manager and later promoted to Senior Manager
2010 – 2011
Kohne Pharma GmbH, Consultant for UCB – Regulatory Affairs International Department (Monheim): Senior Manager and then promoted to Head of Regulatory Affairs
since 2012
acora pharma GmbH (Cologne): Senior Regulatory Affairs Manager
05/2012
Aquired expert knowledge as Qualified Person according to the EU Directive 2001/83/EC

Dr. Marko Kaulich

Senior Regulatory Affairs Manager

1994 – 1999
Studied Pharmaceutics, Rheinische Friedrich-Wilhelms-University Bonn
01/2000
License to practice as Pharmacist
2000 – 2003
Doctorate, Rheinische Friedrich-Wilhelms-University Bonn
12/2003
Graduated as Dr. rer. nat.
2004 – 2010
betapharm Arzneimittel GmbH (Augsburg): Regulatory Affairs Manager and Change Control Manager, later promoted to Group Manager Change Control Europe
11/2006
Appointed as Pharmacist for Drug Information
07/2010
Graduated as Master of Drug Regulatory Affairs (MDRA) after postgraduate studies, Rheinische Friedrich-Wilhelms-University Bonn
2011 – 2014
IPMB GmbH – Regulatory Affairs CMC (Radolfzell): Manager and later promoted to Senior Manager
2015 – 2016
B. Braun Melsungen AG – Global Regulatory Affairs Department (Melsungen): Senior Regulatory Affairs Manager
02/2016
TÜV Süd Academy, Training as Regulatory Affairs Manager TÜV
2016 – 2018
Sanofi Cologne (A. Nattermann & Cie GmbH) – Department New Product Development (Cologne): Senior Regulatory Affairs Manager CMC
since 2018
acora pharma GmbH (Cologne): Senior Regulatory Affairs Manager

Dr. Frank Michaelsen

Senior Regulatory Affairs Manager

1988 – 1997
Studied Biology, University of Cologne
1997 – 2001
Doctorate, Internal Medicine III, University of Cologne
08/2002
Graduated as Dr. rer. medic
2001 – 2003
Department of Endocrinology, University of Cologne: Research Scientist
2003 – 2008
SCHWARZ Biosciences GmbH - Pharmacology/Toxicology (Monheim): Scientific Writer / Document Manager
2008 – 2013
UCB Biosciences GmbH - Global Medical Writing (Monheim): Electronic Clinical Document Manager
08/2011
Graduated as Master of Drug Regulatory Affairs (MDRA) after postgraduate studies, Rheinische Friedrich-Wilhelms-University Bonn
2013 – 2018
UCB Biosciences GmbH - Global Regulatory Affairs (Monheim): Regulatory Submission Manager
since 2018
acora pharma GmbH (Cologne): Senior Regulatory Affairs Manager

Anke Schmalbach

Regulatory Affairs Expert

1988 – 1991
Education as an Pharmaceutical Technical Assistant (Cologne)
1991 – 2001
Pharmaceutical Technical Assistant in various pharmacies (Cologne)
1992 – 1998
Studied Pharmacy, Rheinische Friedrich-Wilhelms-University Bonn
2001 – 2005
Opfermann Arzneimittel GmbH (Wiehl): Regulatory Affairs Assistant
2005 – 2007
Basics GmbH (Leverkusen): Regulatory Affairs Assistant
2007 – 2011
Pharma Westen GmbH (Leverkusen): Regulatory Affairs Assistant
since 2011
acora pharma GmbH (Cologne): Regulatory Affairs Expert