You are busy with the development of an exciting ATMP and planning of production and approval are the next steps to think about? Therefore you want to make sure that you follow the AMG and the ATMP-GMP guidelines and that your processes, premises and equipment is in compliance with the regulatory requirements? Are you planning or looking for a suitable production site to manufacture your ATMP investigational medicinal production?
With us you will reach your goal directly!
Valicare’s scientists and GMP experts support you during development. They validate your process and transfer it into the GMP environment right through to production, approval or hospital exemption of your ATMP. With a risk-based approach, state-of-the-art science and technology and always in compliance with the required regulation, our experts get your product ready for market!
Seminars & training
GMP and especially ATMP GMP seminars, but also on-site training to ensure GMP-compliant behavior during whole production processes of ATMP are part of our services, too.
Our ATMP service includes:
- GMP Compliance Analysis
- GMP process design
- Preparation of an ATMP manufacturing concept
- Risk and quality management and risk analyses
- Securing your sterility requirements including virus security
- Preparation and review of an ATMP development report
- Preparation and review of SOPs + Batch Records
- Process transfer and transfer validation
- Validation of analytical methods, chemical as well as biological
- Basic training GMP for ATMPs
- Strategies for cost reduction and market supply
- Qualification of rooms, equipment and plants
- Container Solutions & Commissioning
- On-site GMP training for personnel
If you work with us, you decide for:
Competence, Reliability & Efficiency
- Competence for customer-specific consulting & safety in the application of the relevant regulation, especially for ATMP
- Reliability in resource planning & project execution
- Efficiency in achieving your time-to-market goals & increased productivity through time and personnel savings
Our experts answer questions about GMP compliance of your ATMP – regardless of whether you are still in development or already planning a clinical trial. 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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