ATMP

We provide comprehensive consulting services in the following areas:

Z
Preparation of Pharmaceutical Quality System (PQS) documentation
Z
Development of User Requirement Specifications (URS) for cleanrooms
Z
Support in qualification and validation processes
Z
Preparation of regulatory strategies for Advanced Therapy Medicinal Product development or grant applications
Z
Internal training programs for ATMP manufacturers

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:

Z
Drafting policies, procedures, and quality manuals tailored to ATMP production.
Z
Establishing risk management frameworks for the entire lifecycle of ATMPs.
Z
Preparing documentation for compliance with GMP (Good Manufacturing Practices) specific to ATMPs.
Z
Assisting in internal audits and gap analyses to ensure regulatory alignment.

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:

Z
Defining User Requirement Specifications (URS) that align with ATMP production standards.
Z
Advising on contamination control measures, HVAC systems, and environmental monitoring requirements.
Z
Supporting the design and layout to meet ISO 14644 and GMP standards.
Z
Collaborating with architects and engineers to implement functional and compliant cleanroom solutions.

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:

Z
Developing validation master plans (VMP) for facilities, equipment, and processes.
Z
Supporting installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Z
Assisting with process validation, ensuring compliance with GMP requirements.
Z
Providing expertise in analytical method validation and ensuring data integrity throughout the production process.

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:

Z
Advising on the classification of ATMPs (e.g., gene therapy, somatic-cell therapy, tissue-engineered products).
Z
Preparing detailed development plans aligned with regulatory requirements.
Z
Supporting grant applications by aligning project goals with funding criteria and regulatory pathways.
Z
Engaging with regulatory authorities for early scientific advice to streamline approval processes.

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:

Z
GMP requirements for ATMPs, including Annex 2 specific guidance.
Z
Risk management strategies tailored to ATMP production.
Z
Validation and qualification protocols, including best practices for cleanrooms and equipment.
Z
Quality assurance and control processes critical to ATMP lifecycle management.

Our training programs are tailored to individual needs and help build competent teams capable of meeting regulatory and operational requirements.