Pharmaceutical Industry & Biotechnology


Companies in the pharmaceutical industry – chemical and biotechnological manufacturers of original preparations as well as generics – are increasingly operating in an area of tension between rising costs and high demands from a wide range of stakeholders. It is often difficult to meet the demands of suppliers, investors, customers (patients, clinics, pharmacies) and the public (society, authorities, state) and at the same time to act economically. In addition, there are high regulatory requirements such as the German Medicines Act and GMP regulations (EU GMP Guide/EU GMP Annexe, FDA CFR Title 21, ICH International Conference on Harmonization).

In order to take into account the current changes and ensure sustainable success, traditional processes need to be re-examined.

While research-based pharmaceutical companies focus primarily on their product pipeline and R&D processes play a central role in the company, generic companies need to convert expiring patents into marketable products as quickly and efficiently as possible and to produce cost-effectively.

With more than 25 years of experience as well as numerous successfully implemented projects, we understand the challenges of our clients in the pharmaceutical industry and have developed our own methods and tools to specifically address these and support our clients in ensuring patient safety.

We have built up deep industry and process know-how and advise along the entire product life cycle:

DHC Consulting Solutions and Services for the Pharmaceutical Industry

As specialists in “Best in Class” processes in the life sciences, in addition to our core competencies we can advise you on the following topics:

Optimisation and standardisation of business processes and IT systems through the implementation of SAP S/4HANA (SAP Intelligent Enterprise)


  • Supply Chain Management
  • Sales
  • Manufacturing
  • Procurement
  • Warehouse Management
  • Quality Management
  • Plant Maintenance
  • Finance
  • Human Resources

Here you will find our consulting services for a fast, secure and compliant implementation of e.g. SAP S/4 HANA.

Einführung/Umsetzung IDMP in SAP


  • Definition of the specific IDMP requirements
  • Identification of the necessary data
  • Creation of the data model for IDMP
  • Implementation and validation of the IDMP solution in SAP (Polaris)
  • Validation of the implementation

Here you can find our consulting services on the topic of IDMP.

Realisation of a standardised LIMS with SAP QM

for the processes:

  • Quality planning
  • Quality inspection (incoming goods inspection, in-process control, release inspections, supplier certificates)
  • Quality costs
  • Product release
  • Certificates of Analysis
  • Supplier qualification
  • Test equipment management
  • Quality evaluations
  • Audit management
  • Stability studies
  • Statistical process control

Here you will find our consulting services on the subject of LIMS with SAP QM.

Implementation of a global deviation / CAPA system based on SAP S/4HANA Quality Management, SAP Quality Issue Management (QIM) or SAP Quality Issue Resolution (QIR)


  • Customer complaints
  • External and internal problem reports
  • Supplier complaints
  • Audit findings
  • Measures management
  • GxP-compliant documentation of deviations with the measures taken

Here you will find our consulting services on the subject of deviation management/CAPA, SAP Quality Issue Management (QIM) and SAP Quality Issue Resolution.

Design and implementation of software validation

  • ERP systems
    • SAP (S/4HANA, ECC, Business One)
    • Oracle Applications
  • Microsoft (Navision, D365)
  • Cloud-based systems
  • Cloud infrastructure service providers
    • Amazon Web Services
    • Microsoft Azure Cloud
  • Manufacturing Execution Systems (MES)
    • SAP Digital Manufacturing Cloud
  • Microsoft Office applications with Excel
  • Document management systems (eDMS)
    • EMC Documentum incl. special interfaces with QUMAS, DocCompliance, First Doc, McLaren, C6
    • Saperion
    • ELO, etc.
  • Laboratory Information Management Systems (LIMS)
    • Labware
    • SampleManager
    • KinLIMS
    • SAP QM
  • Application Life Cycle / IT Service Management Systems (ITSM)
    • SAP Solution Manager
    • ServiceNow
    • HQ Quality Center
    • BMC Remedy Action Request System
    • Frontrange ITSM, etc.
    • Siemens Polarion
  • IT systems in the clinical area
  • Clinical Trial Management Systems (CTMS)
  • IDMP systems (Gramont, etc.)
  • Pharmacovigilance systems (ARISg, PV-Works, etc.)
  • In-house software developments
  • Facility Management Systems

Here you will find our consulting services on software validation/computer system validation (CSV).

Digitalisation of Validation

Among other things, DHC provides support in:

  • Conception of the digital validation strategy
  • Automation and digitalisation of validation processes
  • Central management of validation documentation
  • Automated testing

Here you will find our consulting services on the topics of Digital Validation Scorecard, VxP | Validation Platform.

Managed Services in the Validation of SAP Systems

  • Adoption of change processes
  • Maintenance of the valid state
  • Adaptation of validation documentation

Here you will find our consulting services on the topic of Managed Validation Services.

Request information!

Learn more about the DHC consulting topics for the pharmaceutical industry!


Each industry has its special features and specific requirements, such as the relevance of particular economic, legal and political circumstances, specific requirements for quality and safety, and so forth.

This is why we supplement our core topics of

with our own, industry-specific consulting services. These services are based on our broad-based process know-how, combined with our long experience in the relevant sectors. This secures a long-term competitive advantage for your business.

Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0

Matthias Bothe
Carsten Buri

CEO and Director Sales & Marketing, DHC Switzerland

phone: +41 44 500 888 7

Carsten Buri



29. September
DHC web session (in German)

Public cloud solutions in the life sciences (opportunities & risks)

What should be considered when using public cloud systems with regard to GxP compliance and validation?

06. October
DHC web session (in German)

Qualification of IT infrastructure and cloud-based infrastructure

Implementation of the requirements for GxP-compliant operation of the IT infrastructure in accordance with ITIL and GAMP Good Practice Guide

12. October
DHC & LSA Web session (in German)

SAP S/4HANA Implementation and Validation in the Life Sciences Industry

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

20. October
DHC Websession

Test equipment management and maintenance in SAP S/4HANA

The availability and readiness for use of operating and testing equipment is becoming an important competitive factor for companies.

07. November
Life Online Training

SAP: Validation and GMP Compliance (Live Online Training der ECA Academy)

Online training with speakers from DHC GmbH, organised by Concept Heidelberg on behalf of the ECA Academy,

09. November
DHC & LSA Web session (in German)

SAP S/4HANA Transformation and Validation in the Life Sciences Industry

Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.

17. November
DHC web session (in German)

Inspection planning and results recording in SAP S/4HANA

Web session on new apps for inspection planning and results recording in SAP S/4HANA.

24. November
DHC web session (in German)

Lab IT Compliance using the example of the validation of a CDS


Our web sessions are provided as a free service for DHC customers and potential customers.