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:

for:

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.

for:

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.

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.

for:

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.

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).

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.

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.

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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.

Germany

Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com