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GMP-Consultant
about us
Live your profession
Pooling expertise
Cellmanufactur stands for expertise in Life Science and pharmaceutical industries.
We develop for Start-ups and growth industry individual solutions for the entire value- chain for your product.
We develop for Start-ups and growth industry individual solutions for the entire value- chain for your product.
The entire team is highly motivated and specializes in
completing projects in close cooperation with our clients.
completing projects in close cooperation with our clients.
Cellmanufactur is a synonym for highly skilled people in the field of Life Science and pharmaceutical sector. Depending on the individual project requirements we deliver comprehensive services as required.
You can flexibly use our skills for partial services or total solutions: starting from the evaluation of your project about developing a draft of a master plan and taking the necessary measures in your firm.
Service
Good Manufacturing Practice
Quality assurance is an essential item in the manufacturing of pharmaceuticals and active agents and compliance with laws and directives will guarantee a high level of protection for consumers. Also for cosmetics the necessary assurance that the product is in compliance with the binding standards plays a central role for marketing of such products.
All information and documentation prepared as eCTD-Modules meet the regulations to apply for an approval or authorization for a medicinal product.
In the development of your new drug we are pleased to coordinate project details within the scope of a forthcoming Scientific Advice procedure between the company and the responsible legal authority.
Together with our study nurse and in close cooperation with a CRO we also offer survey for the application and supervision of clinical trials (application for ethical approval, study protocol, IMPD/IB)
In the development of your new drug we are pleased to coordinate project details within the scope of a forthcoming Scientific Advice procedure between the company and the responsible legal authority.
Medical Affairs
Drug manufacture
Product quality requires sound knowledge of GMP laid down in the good manufacturing practice guidelines of the EU. There will have to be high quality and safety standards for all stages of the process, from the choice of starting material to manufacturing and formulation, a drug goes through various tests and certain quality standards have to be met. Manufacturing and quality testing must be performed under specific hygiene rules by trained personnel in a GMP facility only Working together with you we develop or check your process on GxP compliance and accompany you on all the project development phases to the market launch of the new drug.
Upon request, we write in cooperation with you all documents, required for your manufacturing process- just get in touch with us. Specific tasks and a possible time flow are discussed within the framework of a preliminary talk.
Upon request, we write in cooperation with you all documents, required for your manufacturing process- just get in touch with us. Specific tasks and a possible time flow are discussed within the framework of a preliminary talk.
