PVA-2025Herunterladen
SCHOLZ Pharma GmbH was founded by Dr. Bianca Scholz in 2007 and offers business consulting and services in the field of pharmaceuticals (pharmaceutical / medical / healthcare). In addition to our core competencies of audit and inspections in the areas of GCP, GLP, GMP and GVP, our team at SCHOLZ Pharma GmbH also offer customized solutions in the field of pharmaceutical management, coaching, training and document management from development to market presence. SCHOLZ Pharma GmbH works closely together as a team in order to be able to offer you a comprehensive service in the field of GxP. Our experts for the respective areas of GxP support you individually or as a team to meet your specific requirements. In addition to our core competencies, SCHOLZ Pharma GmbH works closely with experts in the following guidelines.
Dr. Bianca Scholz is pharmacist since 1996 with a PhD in the field of neonatology/gynecology. She holds a certificate as Lead Auditor following ISO 19011 and ISO 9001 as well as Quality Manager and Management Technician within the European Organization for (EOQ). Furthermore, she has a supplement qualification for drug safety information and the Management of Public pharmacies with focus on the following areas of expertise:
Dr. Bianca Scholz worked for Baxter Healthcare (2002-2008) as Quality Manager/Auditor in the Team of Corporate Compliance Services. She was Lead Auditor for Pharmacovigilance audits (GVP) and audits of clinical trials (GCP) and supported the Team as Subject Matter Expert in other GxP fields (GMP, GLP, GDP). The audits were performed worldwide. Dr. Bianca Scholz founded Scholz Consulting & Project Management in 2008 (ScholzPharma GmbH since 2015). Since than Dr. Bianca Scholz and team provide services to multiple worldwide operating companies with focus Audit Management, Inspection Readiness Projects, GAP analysis, support in Corrective/Preventive Action Management, Set-up of SOP Systems and assessment of Quality Management Systems.
In addition, Dr. Bianca Scholz provides services as Head of Quality Control (Leiter Qualitätskontrolle) in the GMP environment for small and middle size companies. Dr. Bianca Scholz prepared, supported and attended as Consultant several inspections by Competent Authorities such as FDA/US, MHRA/UK, ANSM/FR, EMA/EU, PEI-Paul Ehrlich Institut/Germany, SwissMedic/CH, BfArM-Bundesinstitut für Arzneimittel/Germany as well as several Federal German Authorities e.g. Regierungspräsidium Tübingen, Karlsruhe, Darmrstadt etc.
Associations, activities and membership:
Dr. Bianca Scholz is speaker for:
In order to build and maintain the strong business and quality results we rely on the strong abilities, competencies and passion of every single member of our team. We believe to accomplish strong results of high quality in collaboration with cross functional colleagues providing holistic and superior results, packages, concepts, and processes for you as our customers. ScholzPharma GmbH will ensure to assign the resources with the needed expertise and training history according to your specific needs.
Satisfied customers who are convinced of our services. We are proud of that and give our best every day.
SCHOLZ Pharma GmbH unterstützt Sie mit Auditerfahrung weltweit. In der Vergangenheit haben wir unsere Auditfähigkeiten in folgenden Ländern unter Beweis gestellt:
Our customers are the best judges of how good we really are. Here are some opinions
Dr. rer. nat. Ulrike MeyerHead of QA Vigilance & Auditing – Global QA R&D „Ich bedanke mich noch einmal sehr herzlich bei Ihnen für das konstruktive, produktive und kollegiale Audit. Da ja aller guten Dinge Drei sind, stehen die Chancen nicht schlecht, dass wir uns bestimmt noch einmal wiedersehen, … und wenn es ein Audit ist. 😉
Susan TimeusTeam Lead Drug Safety „Dr. Bianca Scholz has been our PV Auditor since 2016 and her role has been recently expanded to include GCP audits. She conducts internal audits as well as external audits of third Parties on our behalf. She also provided valuable assistance in design of the company risk based PV audit strategy. She brings with her a thorough knowledge of applicable PV, GCP and GxP regulations, guidelines, policies and procedures. In addition she has excellent interpersonal skills and provides pragmatic solutions to identified gaps in processes. I can highly recommend Dr. Bianca Scholz as an auditor.“
Alexa TulaszewskiHerstellung und Vertrieb, med. technischer Geräte und Arzneimittel
“Frau Dr. Scholz hat uns von der ersten Minute an bei der Etablierung eines Pharmakovigilanz-Systems für unsere neue Arzneimittelproduktion beraten und ist für uns als pharmazeutisches Unternehmen unersetzlich geworden! Von Beginn an hat sie uns perfekt darin beraten, was für uns als kleines Unternehmen mit wenigen Produkten notwendig ist und wie die Erfordernisse am besten umzusetzen sind. Jede Frage wird umgehend beantwortet und auch kurzfristig angefragte Schulungen oder Überarbeitungen werden stets durch Frau Dr. Scholz möglich gemacht. Wir sind sehr froh, Frau Dr. Scholz als Beraterin an unsere Seite zu haben.“
Martin DornseiffHead Corporate Drug Safety and Labelling, EU-QPPV
„Seit 2018 beauftragen wir Frau Dr. Scholz regelmäßig mit PV-Audits bei unseren Distributionspartnern, teilweise kombiniert mit GDP-Aspekten. Zusätzlich hat sie auch unser eigenes PV-System im Rahmen eines zweitägigen internen Systemaudits überprüft und eine Reihe sehr zielführender Vorschläge zur weiteren Optimierung gemacht. Hervorheben möchte ich ihre wichtigen Impulse zur Weiterentwicklung einer auf unser Unternehmen zugeschnittenen risikobasierten PV-Auditstrategie. Wir haben besonders ihre offene, souveräne und lösungsorientierte Herangehensweise, ihren breiten Erfahrungsschatz im GVP- und GDP-Bereich und ihre Flexibilität in Hinblick auf die aus der jeweiligen Vertragssituation erwachsenden Bedürfnisse schätzen gelernt.“
STEPHAN HAMANN, PHDTeam PV Quality Systems
Pharmacovigilance and Medical & Scientific Affairs For the conduct of an internal audit at our Pharmacovigilance and Medical Scientific Affairs department, we were able to engage Dr. Bianca Scholz. As a result, we received a very comprehensive and professional assessment of our pharmacovigilance (PV) system, focusing on the interfaces between company-internal departments, international collaboration, and related contract management as well as compliance with local (GVP) and global regulations. Dr. Bianca Scholz has a high level of expertise in auditing and a profound knowledge of PV requirements and related expectations of authorities worldwide. In addition, she is open-minded, has excellent interpersonal skills and excellent communication skills. We are very grateful to her for carrying out the audit and assessment of our PV system.
Dr. Bettina FiskHead of QA Vigilance & Auditing – Global QA R&D “In view of an upcoming GVP related Regulatory Authority inspection, Dr. Bianca Scholz’ support has been of great value due to her profound knowledge in Pharmacovigilance regulations, guidelines, procedures and processes. She made significant contributions to understand Pharmacovigilance related expectations especially with focus interdepartmental connections and impact within our company.
Her wealth of experience in interpersonal skills guiding a learn process to find company specific solutions and process improvement was very constructive. We appreciate her open-minded advice and targeted assistance and can always recommend her as consultant and auditor.”
Barbara-SylviaBracht-WeigandSenior Manager Drug Safety „Ich fand es ein sehr angenehmes und hilfreiches Audit und Ihren Ansatz sehr gut. Man fühlt sich nicht nur einfach auditiert, sondern gleichzeitig gut beraten, wie man‘s verbessern kann. Ich hoffe, wir werden irgendwann noch einmal gemeinsam Audits haben! “
Cornelia KrüskeSenior Pharmacovigilance & Quality Manager Vielen Dank auch für das Audit. Ich habe viel Spaß und Freude gehabt, bei dem Tag, sofern man es sagen darf, wenn es um ein Audit geht 😉 Ich bewundere Ihre Souveränität im Umgang mit dem Kunden. Ihre jahrelange Erfahrung war absolut spürbar. Es ist ein Geschenk für uns, mit dir zu arbeiten.
PVA-2025Herunterladen
