Gradocell is a consulting and CRO (Contract Research Organization) Spanish, founded in 2010, offering advisory services (technical and documentary) and training standards (GMP, GLP and GCP) in the field of advanced therapies (cell therapy, gene and tissue engineering) and Innovative Medicines and the preparation of necessary documents and monitoring of clinical trials in this area of biotechnology.
Our objective is to become the reference consulting company and CRO in Spain, and we are directed to companies and laboratories interested in implanting quality in both research and products belonging to advanced therapies.
Gradocell services are focused on consulting and helping our clients in their process to obtain and implement autorization regarding Cell Therapy regulations. We also give advice in documentation and procedures for addressing these guidelines. At Gradocell we can offer:
- GMP for advanced therapy laboratories
- Preparation of audits and inspections by regulatory agencies
- Specialized technical consulting in cell therapy processes
- consulting and elaboration of documents for clinical trials in advanced Therapies (IMPD, researcher manual, etc.)
- Monitoring of clinical trials in advanced therapies
We advise and train your staff in all levels of the process: documentation, facilities, validations, etc. Our training offer in specialized in the preparation of: quality managers, manufacturing managers, production technicians, quality control managers, quality control manager, technical manager.