ATMP
We provide comprehensive consulting services in the following areas:
Our services help ATMP manufacturers meet high regulatory requirements, achieve operational excellence, and ensure compliance with regulations.
Preparation of Pharmaceutical Quality System (PQS) Documentation
We offer comprehensive support in developing and implementing a robust PQS that complies with ATMP-specific regulations, including:
Our services help meet regulatory requirements and build an effective quality management system for ATMPs.
Creation of User Requirement Specifications (URS) for Cleanrooms
Our expertise helps ensure cleanroom facilities meet all regulatory and operational needs by:
Our services help create infrastructure that supports the safe and compliant production of ATMPs.
Support in Qualification and Validation Processes
We guide clients through the complex processes of qualification and validation critical for ATMP production by:
Our services help clients meet the highest regulatory and quality standards, supporting the reliability and compliance of ATMP production processes.
Development of Regulatory Strategies for Product Development or Grant Applications
Our team provides tailored regulatory strategies to facilitate ATMP development and funding opportunities, including:
Our services help companies navigate the complex regulatory environment effectively and maximize the chances of success for ATMP projects.
Internal Training Programs for Manufacturers
We deliver targeted training solutions to empower ATMP manufacturers with the knowledge to achieve compliance and operational excellence, focusing on:
Our training programs are tailored to individual needs and help build competent teams capable of meeting regulatory and operational requirements.