Schwyzerdütsch
EnglishPharmaceutical Industry & Biotechnology
PHARMACEUTICAL INDUSTRY AND 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:
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.
Learn more about the DHC consulting topics for the pharmaceutical industry!
WHY CHOOSE DHC?
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.
Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com
CEO and Director Sales & Marketing, DHC Switzerland
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch
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