Valicare – Quality and GMP Services for R&D

Syntegon offers a wide range of services in the field of risk-based qualification and validation of plants, equipment and processes. Our subsidiary Valicare GmbH supports our customers in the GMP-compliant development of clinical trial products.

The team of specialists implements and documents central qualification and validation steps based on comprehensive process and GMP expertise and in compliance with national and international guidelines. Together with our customers, we take the approach to a product that is specified safely and in accordance with the requirements, no matter whether it belongs to the classical class of medicinal products or to advanced therapy medicinal products.

Our service spectrum includes:

  • Process risk analyses and process control strategies
    We provide iterative risk analyses up to the definition and documentation of the required validation activities and define the parameter corridor (design space) for process control together with our customers.
  • Analytics and quality controls
    We provide guidance in the selection and definition of analytical methods derived from the process control strategy, prepare test instructions and documentation for verification and validation.
  • In-house GMP manufacturing
    We provide the required GMP documentation, quality management instructions and binding guidance documents.
  • Supplier audits
    To ensure the pharmaceutical quality of our suppliers, we carry out graduated qualification measures, where required on a risk basis – from obtaining certificates to on-site supplier audits.
  • Pilot plant planning, construction and ready-to-operate installation
    We are the one-stop solution for planning, construction, equipment, and ready-to-operate installation of pilot plants, including all necessary qualification and validation services.
  • Process transfer to contract manufacturer
    We support the search, selection and qualification of a suitable manufacturer.

Contact

Valicare GmbH
Eschborner Landstraße 130-132
60489 Frankfurt am Main

Phone: +49 69 153 293 701/709

E-mail

Your advantages:

  • ISO 9001-certified GMP service company
  • GMP development according to ICH, EU and cGMP Guidelines
  • Product- and process-oriented service
  • Consulting services and training tailored to individual customer needs
  • The cult.tainer concept allows a faster production of ATMPs

Valicare supports customers from the very beginning in deciding which qualification and validation services are best suited to your needs. Please don´t hesitate to contact us!

 

Dr. Hans-Georg Eckert

Dr. Hans-Georg Eckert

Senior GMP Consultant & Project Manager
GMP

E-mail

Mohsen Masoumi

Senior GMP Consultant & Project Manager
Active Pharmaceutical Ingredients

E-mail

Mohsen Masoumi
Dr. Claudia Papewalis

Dr. Claudia Papewalis

Senior GMP Consultant & Project Manager
ATMPs

E-mail