GMP Consulting
The Valicare GmbH supports you extensively with the implementation of the EU GMP guidelines. Thus, your focus can stay on your all-day work.
You are intending a GMP-compliant manufacturing of a pharmaceutical product and you are looking for competent support for the application of manufacturing authorization? You want to make sure your ongoing processes, equipment und plants are in accordance to GMP requirements and will withstand audits and inspections? Then trust in our expertise.
The Valicare GmbH offers a wide range of services in terms of Good Manufacturing Practice (GMP) compliance. Whether concerning GMP compliance, GMP consulting or execution of qualification and validation, we support you extensively with the implementation of your projects.
We are ISO 9001 certified and work internationally in multidisciplinary teams. Therefore, we continuously gear towards the actual state of the art and worldwide-accepted guidelines.
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Over 1.000 projects successfully realized
A team of permanent consultants and validation experts specialized on different GMP competence fields will provide support with expertise and visions.
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GMP consulting in numerous divisions
We understand the requirements of the pharmaceutical, biotechnology and medical device industries for the production of pharmaceuticals, medical and combination products and advanced therapy medicinal products (ATMPs).
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Wide range of expertise
Our experts offer cross-sectoral solutions for a multitude of prevalent GMP compliance issues supported by consulting but also hands-on activities. Please keep in mind, we can also revert to the expertise of our parent company, Syntegon Technology GmbH, a packaging and process technology specialist.
Cooperating with us implies a decision for:
- Competent, customized consulting
- Confidence in application of relevant guidelines
- Efficient implementation of your time-to-market goals
- Reliable resource planning with experienced consultants
- Outstanding know-how in the field of process technology, primary and secondary packaging
- Increased productivity due to time and personnel savings
We offer support in the following fields:
- GMP-system implementation and upgrade
- Audit and inspection for ISO and GMP compliance – international
- Pharmaceutical procurement and supplier qualification
- DIN EN ISO 13485 and 9001 quality management system
- Process risk management and technical risk analysis
- Risk-based qualification of equipment, plant and production lines
- Validation of systems, methods and processes
- GMP logistics and Good Distribution Practice
- Cleanroom operation and technology
- Excipient/active pharmaceutical ingredient (API)
- Pharmaceutical aseptic manufacturing
- Process technology and pharmaceutical packaging
- GMP workshops and trainings
We offer GMP consulting services at the highest professional and regulatory level. Challenge our competence!
Give us a call
+49 69 153 293 709
+49 69 153 293 700
(according to your tariff for calls to the German landline)
or fill in our contact form:
Get in contact with us!
Our GMP consultants will reply to you as soon as possible without any obligation.
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