Your seamless GMP service provider for pharma, biotech, medtech and cell and gene therapy manufacturers

Are you looking for comprehensive GMP services? Then Valicare is your ideal point of contact. We have been providing a broad range of classical and specialized GMP services to the pharmaceutical, biotechnology, medical devices, and cell and gene therapy industries for more than 20 years.

Valicare is a 100% subsidiary of Syntegon. Our headquarters are based in Frankfurt (Main), Germany, and our sister company in Trenčín, Slovakia. Our broad GMP consulting, qualification and validation portfolio is the ideal complement to Syntegon's seamless single-source pharmaceutical line solutions and those of other providers. Whether you need support in ensuring GMP-compliance, services for cell and gene therapies, risk-based qualification and validation support, Computerized System Validation, CSV, or services for medical devices: Valicare offers the expertise and experience you need to ensure the successful completion of your projects.

Your benefits

Seamless solutions from a single source in collaboration with Syntegon
Risk-based and integrated qualification and validation of your processes – from GMP consultation to implementation
Time and resource savings by entrusting your qualification and validation projects to our highly qualified GMP experts
Short project lead times thanks to efficient planning and execution
Faster market introduction of your new products

Our services

More than 5,000 successfully completed projects all over the world speak for themselves. Valicare is your partner for everything GMP-related. Our senior consultants have been working in the GMP-regulated environment for more than 20 years. They are always up to date with European and international regulations. Moreover, our highly experienced validation experts have a comprehensive technical understanding of process and packaging technology.

Find out more:

cult.tainer® and the Annex 1

Having published a new concept paper on the planned revision of the EU GMP Guideline Part IV, EMA drafts up requirements for manufacturing facilities for the aseptic production of ATMPs. Driven by the preceding publication of Annex 1, contents of Annex 1 pertaining to aseptic manufacture will find their way into the world of ATMPs. Accordingly, our cult.tainer concept is adapting to address these emerging requirements, such as to include unidirectional personnel flow in critical areas.

Info on the cult.tainer®

Our business areas

Our business areas are as diverse as our expertise. We serve the pharmaceutical and biopharmaceutical industry with GMP consulting and qualification and validation services. At the same time, we offer specialized support for cell and gene therapies and medical devices. What all these areas have in common is the need for sustainable and reliable support from a single source. Valicare is here to provide that support.

Find out more:

Over

years of experience

More than

projects per year

Over

employees

This speaks for a cooperation with us:

Minimizing production risk

Extensive experience with pharmaceutical manufacturing requirements

Advance planning and cost forecasting

Immediate setup of manufacturing and quality control concepts

Simplifying complex processes

Extensive expertise regarding the requirements for an optimized pharmaceutical quality management system (PQM)

APV Workshop Cell & Gene Therapy Products

July 14^th, 2025
The interactive APV workshop will highlight Advanced Therapy Medicinal Products (ATMP) as products in development for market supply.

More info

Webinar: CCS for ATMPs

June 3^rd& 5^th, 2025
Join us for a free webinar on contamination control strategies for ATMPs! We will provide an overview of current regulatory developments and emerging challenges, as well as promising strategies to overcome them.

More info

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Further Events

Further events such as conferences, training courses or workshops can be found here.

See the overview

News

05.05.2025

Efficiently documenting a Contamination Control Strategy for Cell and Gene Therapy Products

Preparation of a contamination control strategy for ATMPs is a challenge. Have us support you with our know-how and our upcoming webinar series.

Efficient QMS according to EN ISO 13485: Innovation despite MDR and shortage of skilled workers

The medical device industry is facing major challenges: The MDR (Medical Device Regulation) imposes...

Automation and robotics for ATMPs

ATMPs achieve results in treating incurable diseases. Approved ATMPs are rising, peaking in 2024....

Do your methods comply with the new ICH requirements?

Analytical methods form the foundation of quality control, research, and development.

News from the GMP Market

Current national & international developments as well as news on GMP, ATMP & Valicare topics. ➔ See...

More news

Our international press review contains a selection of news and recent articles on Advanced Therapy Medicinal Products (ATMPs), Chimeric Antigen Receptor T-cell Therapy (CAR) and Tumor Infiltrating Lymphocytes (TILs).

News on cell and gene therapy from around the world

Your career at Valicare

Apply now and start your career at Valicare!
If you have completed a scientific or technically oriented degree and are interested in working in the field of qualification & validation or GMP consulting, have a lot of experience in very different projects and want to seize your opportunities in a dynamically growing company, apply to us.

Learn more

Frankfurt am Main, Germany

Valicare GmbH

Eschborner Landstraße 130-132
60489 Frankfurt am Main
Germany

Opening hours:
Monday - Friday 08:00 - 16:00

Phone: +49 69 153 293 700
Email: info@valicare.com

Your seamless GMP service provider for pharma, biotech, medtech and cell and gene therapy manufacturers

Your benefits

Our services

GMP Compliance

Qualification & Validation

GMP for Cell and Gene Therapy

Isolator Technology

Medical Devices