Technical and regulatory consultancy
Gradocell provides expert regulatory advice tailored to the development and authorization of ATMPs, ensuring compliance with international standards.
Our services include designing quality system, preparing documentation for manufacturing processes, Quality Control, Quality Assurance and Validations.
Communication support with regulatory agencies.
Additionally, we prepare the necessary documentation for each Advanced Therapy Medicinal Product for clients who need to adapt their products and processes in the R&D phase to standardized production under GMP regulations or require transferring their production processes to another manufacturer (CMO).
We collaborate with the client to design the most optimal regulatory pathway and conduct cost studies to determine the investment needed for the development of Advanced Therapy Medicinal Products and new therapies.
We provide support in the design, planning, and development of clinical trials, ensuring adherence to both general and specific Good Clinical Practice (GCP) standards for Advanced Therapy Medicinal Products.
We perform on-site and online external audits, developing corrective and preventive action plans for our clients to ensure their success during regulatory inspections. We also conduct external audits for subcontracted companies (CMOs) and evaluate client suppliers.
Conducting external audits for GMP compliance, including gap analysis, risk assessment, and process optimization. Advanthera Regulatory Pathways offers expert guidance to bring your processes up to standard, ensuring your products are compliant with regulatory expectations.
Personalized and tailored training courses, adjusting the duration and content to meet the specific needs of each organization and client.
· Regulations and legislation for advanced therapy medicinal products
· Quality management and assurance courses
· Technical courses: manufacturing and quality control
Offering in-depth GMP training for your teams involved in the development and production of ATMPs.Training covers essential topics such as documentation, process validation, and regulatory requirements.
We advise, cooperate, and collaborate with clients requiring comprehensive support for the implementation, training, and certification of GMP standards in manufacturing facilities for Advanced Therapy Medicinal Products and Innovative Medicines.
We facilitate collaboration with clinical leaders and assess the feasibility of potential centers and investigator capabilities, supporting the recruitment process.
We handle the initiation of clinical trials, including registration in CTIS and REec. We monitor the progress of studies, proactively identifying issues and implementing the necessary preventive actions.
We offer comprehensive management of data handling and statistical analysis, assisting with the creation and maintenance of the master file (TMF) according to specific requirements.
