We are a leading strategic, technical, regulatory and quality control consulting firm. We work with biotech companies, hospitals, laboratories and research centers who focus on the development of innovative medicines and advanced therapies.
Gradocell is a leading company in its commitment to serve its clients, providing technical, regulatory, strategic and quality systems consulting services in the field of Advanced Therapies and Innovative Medicines.
Gradocell’s services are focused on assisting our clients during the initial phase of the project and during the development phase of this type of medicines. With this purpose in mind, Gradocell closely collaborates with clients in the preparation of project feasibility plans, in providing regulatory and technical advice, in offering the required training and ensuring the correct implementation of the GMP Quality System in accordance with the applicable regulations.
Our team has expertise in all phases of the development of Advanced Therapy Medicinal Products (ATMPs): regulatory strategy, manufacturing processes, quality control, validation, quality assurance, technology transfer and preparation of all regulatory documents as required by GMP standards and for the approval of clinical trials (IMPD). Our twenty years of experience in the field speak for themselves.
Gradocell’s services are focused on offering regulatory, technical and quality assurance support. We also carry out project feasibility studies, we provide ad-hoc training programs, we collaborate in the management of technology transfers, we provide internal auditing services and we prepare the necessary documentation for the manufacturing and approval of this type of medicines.
Gradocell has a wide variety of clients: Hospitals, Foundations, and private and public companies.
Our clients include national and international biotech companies with a high technological level, private clinics and public hospitals with great national coverage, as well as research centers and public organizations, each of them related to and focused on improving people’s health by using high quality and effective medicines based on Advanced Therapies.