BMCT – BioMed Consulting & Training

BMCT is a team of professionals with extensive scientific achievements and experience in collaboration with entities in the pharmaceutical and medical industries.

Medicinal Products

Medical Devices

ATMP

Scope of Services

Tissue and Cell Banks and ATMP (Advanced Therapy Medicinal Products)

We provide a wide range of services in the areas of advanced therapy medicinal product (ATMP) development, including the preparation of documentation:

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of the Quality Management and Assurance System for medicinal products,
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to obtain Authorization for the Manufacture of Advanced Therapy Medicinal Products for Hospital Exemption (HE-ATMP),
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to secure approval from the Ministry of Health,
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to receive the Bioethics Committee’s Consent.

At the Client’s request, we conduct audits of existing ATMP manufacturing technologies and operational systems, as well as participate in necessary inspections and controls.

Additionally, we take part in designing technological and process solutions for Tissue and Cell Banks and medical entities, as well as in the implementation of Good Manufacturing Practice (GMP) principles.

Medical Devices

At the client’s request, we prepare:

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Technical Documentationof the medical device
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Clinical evaluation in accordance with the MDCG and MedDev guidelines
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Support in developing a complete Quality Management System, essential for daily operations

ISO 9001 and ISO 13485

The goal of the Quality Management System is to improve the quality of manufactured products or provided services and enhance customer service. At the Client’s request, we assist in implementing a system from the ground up or in repairing or adapting an existing solution within the organization.

If, based on the description provided on our website, you are unsure whether our offer aligns with your needs, we encourage you to contact us to learn more about the full scope of our capabilities.

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