ScholzPharma GmbH – Consulting & Project Management

WELCOME TO SCHOLZPHARMA GMBH

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.

QUALIFIKATIONEN DR. BIANCA SCHOLZ

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.

MEMBERSHIP

HEAD/TEACHER

Leiterin Arbeitsgruppe Pharmakovigilanz DGGF 2016-2019

Wissenschaftliche Leitung Heidelberger Herbstkongress LAK

Dozentin Universität Heidelberg seit 2019 Rechtsseminar Pharmazie

TRAINER/SPEAKER

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:

Drug Safety /Pharmacovigilance Regulatory Affairs Clinical Trial Management Drug Safety Data Management

Drug development (Good Laboratory Practice GLP) Product quality and product risks (Good Manufacturing Practice GMP) Inspection preparation / corrective action planning (networking with CA).

OUR SEVICE

trainings, workshops and seminars

We offer you in-house training, workshops and seminars on the subject of GxP, as a face-to-face event at your location and, of course, also as an online event. In-house training offers the opportunity to adapt company-specific topics with tailor-made content and focal points to your time and employee needs.

Our team of speakers offers you the optimal insight into everyday working life with in-depth knowledge and many years of experience in the respective specialist areas. Regardless of whether you are a beginner or an expert. We adapt to your needs and the group size of the participants with an individual training offer.

We prepare you for your everyday life but also for audits by your partners or inspections by the authorities responsible for you (inspection readiness).

Do you want to strengthen your team of auditors and need training?

We prepare you for the role of auditor

The speaker Dr Bianca Scholz has been a certified auditor since 2001 EOQ/DGQ (European Organisation Quality/German Society for Quality) and offers insight into the everyday practice of an auditor with more than 20 years of experience in the field of GxP/ISO 9001.

If you are looking for training on other topics or special topics, please contact us. We will certainly find an optimal solution for you.

Audit & Inspection

Numerous legal and regulatory requirements necessitate the execution of audits. Many companies are not prepared for this or deliberately choose to delegate these tasks to an objective service provider. Audits serve the internal control of processes and procedures and make a valuable contribution to the continuous improvement of the processes. SCHOLZ Pharma GmbH carries out audits in all areas of the pharmaceutical industry (GxP) and offers assistance in handling challenging topics and corrective measures. For your individual inspection preparation, SCHOLZ Pharma GmbH can look back on many years of experience in the preparation and support of inspections by authorities (FDA, EMA, PEI, BfArM, EU state authorities). Thus, your team can be prepared by the SCHOLZ Pharma GmbH for the inspection targeted and with company-specific training and the review and adjustment of all relevant documents.

Pharmacovigilance

Drug safety is playing an increasingly important role in the pharmaceutical industry. Both in clinical development and later with marketed drugs, continuous monitoring and controlled documentation are expected by the responsible authorities and required by the law. SCHOLZ Pharma GmbH supports you with implementation and maintenance of your pharmacovigilance system. The services of SCHOLZ Pharma GmbH include amongst other things:

Project management GVP / GCP and interfaces (GxP, RA, QA, marketing and sales)

Creating and customizing process descriptions (SOPs)

Optimization of processes and update to current laws and regulations

Training GVP / GCP and interfaces (GxP, RA, QA, marketing and sales)

Advice on regulatory requirements

Contract management (co-marketing, service providers) Support in the implementation and maintenance of PV systems

Quality Management

The quality management standard ISO 9001 is the most widespread and important international standard in quality management (QM). Certification to ISO 9001 is possible for entrepreneurs and organizations of all sizes and in all sectors and provides the basis for the continuous improvement process of the internal quality management system (QMS).

ISO 9001 specifies the minimum requirements for a quality management system to be implemented by companies in order to meet customer requirements and other product or service quality requirements. In the field of pharmaceuticals, these requirements include all the rules and regulations as well as guidelines, ordinances and special authority requirements that are individually determined and implemented by SCHOLZ Pharma GmbH for customers.

The availability of appropriate process descriptions (SOPs), the implementation of training systems, quality controls, and the regular performance of system audits are essential to ensuring a sufficient quality standard for each company. SCHOLZ Pharma GmbH supports you in the ISO 9001 quality management implementation as well as in the preparation for a certification. We assist you with the daily monitoring and continuous improvement of your quality management system

Clinical Research

Clinical studies are determined by a variety of legal and regulatory requirements. Successful approval of clinical trials is only possible if the clinical studies are planned and carried out in these regulated environments. SCHOLZ Pharma GmbH offers you services in connection with the clinical development of pharmaceuticals in the following scope:

• Contract Research Organization audits

• Audits from testing centers

• Create and maintain the trial master file

• Training for investigators, monitors

• Document Management: Creating & Reviewing Study Documentation, Enrollment Application / EC / CA Approval, Study Design, Study Plan, CRF, Patient Information, Study Reports

Audit & Inspection

Our customer

Satisfied customers who are convinced of our services. We are proud of this and give our best every day.

unser team

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.

We offer you

Pharmacovigilance (PV) training of your PV service providers worldwide

Pharmacovigilanz (PV) Schulungen ihrer PV Dienstleister weltweit

What our customers say about us

Our references

Dr. Bettina FiskHead of QA Vigilance & Auditing / Global QA

Merz Therapeutics

In view of an upcoming GVP related Regulatory Authority inspection, Dr. Bianca Scholzâ 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.

Susan TimeusTeam Lead Drug Safety

Tillotts Pharma AG, Switzerland

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

Telos GmbH

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

InfectoPharm Arzneimittel und Consilium GmbH

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 leistungsorientierte Herangehensweise, ihren breiten Erfahrungsschatz im GVP- und GDP-Bereich und ihre Flexibilität in Hinblick auf die aus der jeweiligen Vertragssituation erwachsenden Bedürfnisse schätzen gelernt.