Services

Our Services.

Gradocell offers the following services with a focus on providing regulatory, technical and quality assurance support: project feasibility studies; specialized training; support in the management of technology transfers; external GMP auditing services; and preparation of the necessary documentation for the manufacturing and approval of this type of medicines.

We help clients in the development of Advanced Therapy Medicinal Products (ATMPs) from the first stages of R&D to the clinical use of the medicine.

We collaborate with our clients in the creation of their strategic plans by defining the optimal technical and regulatory strategies. We also provide technical support to correctly determine the costs and the investment needed to reach the established milestones.

We offer a personalized support service throughout the whole development process before the different Regulatory Agencies (AEMPS, EMA), by providing scientific guidance and addressing any doubts regarding ATMPs.

Technical, regulatory and strategic consulting.

We provide regulatory, technical and quality assurance support as well as project feasibility studies, training, management of technology transfers, auditing services and the preparation of the necessary documentation.

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Training.

Ample training program and seminars in the field of Advanced Therapies, covering different aspects of regulations and development. We also provide training in the peculiarities of Manufacturing and Quality System processes.

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Clinical development

Comprehensive management of clinical research programs in all phases of development. Preparation, review and submission of applications, follow-up, supervision, management and analysis.

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Services

Technical, regulatory and strategic consulting.

1

Assessment of the situation

We assess our clients’ processes to identify areas of improvement as well as the needs of those clients who are first-timers in the adaptation of their processes, facilities and Quality Systems to the Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products (ATMPs).
2

Technology transfer

We provide support in the fine tuning of the manufacturing process from a GMP point of view. We help clients determine the most appropriate manufacturing process, scale-up, validation and quality control. We also elaborate the necessary documentation for each Advanced Therapy Medicinal Product (ATMP) for those clients who need to adapt their R&D products and processes to standardized GMP manufacturing or who need to transfer their manufacturing processes to another manufacturer (CMO).
3

Implementation of Good Manufacturing Practices (GMP)

We advise, cooperate and collaborate with clients who need our wholistic consulting services for the implementation, training and GMP certification of manufacturing facilities for Advanced Therapies and Innovative Medicines.
4

Technical Advice

We provide personalized advice throughout the entire manufacturing process and quality controls, from the perspective of GMP regulations. We also give advice on the planning of the necessary validation, as well as on the design and adaptation of facilities and equipment, appropriate clothing and regulations for the access to and work in rooms with a controlled environment.
5

Quality Management Advice

We support and assist clients in all tasks relating to their Quality System and organization. We also collaborate in document and non-conformity management, change control and risk management.
6

Integration of the GMP regulations in other certified Quality Systems. Auditing

We perform external on-site audits and documentary online audits, and provide remedial and preventive action plans for our clients, to guarantee their success during the inspection by the regulatory authorities. We also perform external audits on outsourced companies (CMOs) and we evaluate our clients’ suppliers.
7

Elaboration of quality documentation

We prepare specific documentation and elaborate standardized working procedures; validation protocols adapted to your organization; processes and a Quality System that will comply with the requirements of Quality Standards.
8

Preparation of the application document for the Use Authorization

We prepare the documentation to apply for the Use Authorization for Advanced Therapy Medicinal Products (ATMPs) (quality, clinical and non-clinical documentation) of non-industrial manufacturing, in the context of hospital institutions.
9

Scientific advice on Regulatory Agencies (AEMPS and EMA)

We guide our clients in the process and prepare scientific advice procedures for medicinal products for human use in AEMPS (Spanish Agency of Medicines and Medical Devices) and/or EMA (European Medicines Agency), and provide advice on any issue relating to the development of said products.
10

Project feasibility studies

We collaborate with our clients in the design of their optimal regulatory path. We also make a financial assessment to determine the investment needed for the development of medicines for Advanced and Innovative Therapies.
11

Preparation and review of Clinical Trial application forms

We prepare and/or review the Investigational Medicinal Product Dossier (IMPD), based on the documents shared by the client as well as the Research Protocol.
Services

Training and Seminars.

Gradocell offers a wide range of training programs and seminars in the field of Advanced Therapy, covering different aspects of regulations, development and the specifics of Manufacturing and Quality System processes for Advanced Therapies and Innovative Medicines.

We offer personalized training courses, adapting length and content to our client’s specific needs. In addition to theory, GRADOCELL’s training includes an important practical component, with real-life examples, ensuring the client successfully acquires the corresponding knowledge. 

Seminarios y jornadas especializadas.

Seminars and specialized conferences.

We offer both in-person and online training. In-person training usually takes place in our clients’ facilities, making it easier for personnel to attend and facilitating the practical application of the theory to the client’s own system and organization.

Gradocell’s teachers and advisors have ample experience in the field, both in the business and hospital contexts, particularly in the areas of Quality Assurance, Regulations, Manufacturing and Quality Control.

We give clients all the necessary teaching material, as well as the corresponding Training Certificate to certify their employees’ training.

We organize and participate in seminars and specialized conferences to increase awareness of our field.

Training Areas

Personalized training courses that are adapted in length and content to the organization’s and client’s needs.

Standards and Regulations for Advanced Therapy Medicinal Products (ATMPs)

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Courses on Quality Management and Quality Assurance

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Technical Courses: Manufacturing and Quality Control

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Services

Clinical development

We provide turnkey solutions to our clients’ clinical program in all phases of clinical research. From supporting the preparation, review and submission of Clinical Trial Application (CTA) forms, Investigational Medicinal Product Dossier (IMPD), Protocol, Informed Consent Form (ICF), Investigator’s Brochure (IB), and overall clinical trial documentation, to overseeing running of trials, data management and analysis, and pharmacovigilance.

1

Strategic Advice

We assist in the design, planning and development of clinical trials, guaranteeing adherence to Good Clinical Practices (GCP), including those specific to Advance Therapy Medicinal Products.
2

Selection of research sites and personnel

We mediate collaboration with key opinion leaders and assess feasibility and capabilities of potential research sites and personnel, providing support with contracting.
3

Clinical trial oversight and management

We manage clinical trial set-up and initiation, including registration on CTIS and REec. We monitor clinical trial running, proactively working on detecting deviations and implementing the necessary corrective and preventive actions.
4

Data handling

We facilitate data management and analysis, as well as help compile and maintain the Trial Master File (TMF) according to needs.