We assess the current state of our clients’ processes, identifying areas for improvement and needs for those facing the adaptation of their processes, facilities, and Quality System to the Good Manufacturing Practice (GMP) environment for Advanced Therapy Medicinal Products (ATMPs) for the first time.

We provide guidance on setting up the manufacturing process from a GMP perspective, defining the appropriate production process, scaling, validations, and quality controls. 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 provide personalized consulting throughout the entire manufacturing and quality control process from a GMP regulatory standpoint. We also advise on the planning of necessary validations, as well as the design and adaptation of facilities and equipment, appropriate attire, and access and work standards in controlled environments.

We support and assist in all activities associated with the Quality System and its organization. We also cooperate in document management, non-conformity handling, change control, and risk management.

We prepare specific documentation and write standard operating procedures, validation protocols adapted to the organization, and processes and Quality Systems that comply with the requirements of various Quality Standards.

We prepare documentation to obtain authorization for the use of Advanced Therapy Medicinal Products (quality, clinical, and non-clinical documentation) for non-industrial manufacturing in hospital institutions.

We assist and prepare scientific advisory procedures for human-use medicines with AEMPS (Spanish Agency for Medicines and Health Products) and/or EMA (European Medicines Agency), as well as any inquiries related to the development of these products.

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.