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Advanced Therapy Medicinal Products (ATMPS)
ValSource consultants have unparalleled expertise to help navigate the complex regulatory environment of ATMPs. We provide full services for key challenges including employing a science driven, risk-based approach to ensure success.
Our consultants are widely known as thought leaders on ATMP development and manufacturing.
An Emerging Field
Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, cellular therapy, and tissue-engineered products. The development of ATMPs is a dynamic and fast-growing field of interest. Although most of the products are in an early development phase, the combined trial phase and the potential to cure severe chronic conditions suggest that ATMPs may reach the market earlier than standard therapies. In just the past few years, there have been many approvals of ATMPs by global regulatory agencies. Hundreds of these therapies are now rapidly moving through clinical development, which presents unique challenges to the development and manufacture of these products.
Industry Experts
ValSource consultants are the industry’s leading experts on ATMP development, manufacturing, quality and compliance. While other consultants may know the standards, ValSource consultants write them. Our consultants have worked alongside regulators to author guidance documents, technical reports, white papers, and standards. Our consultants have extensive experience through all stages of product lifecycle with both established companies and startups.
Ways We Can Help
Facility:
Facility and equipment procurement and design consultation
Commissioning, Qualification, and Validation of Facility, Utilities, Equipment, and GMP systems
Calibration & Metrology and Preventive Maintenance services
CDMO vetting and selection
Site Specific Safety Plan (SSSP)
Process:
Process validation lifecycle (design, qualification, and continued process verification)
Control Strategy establishment including process characterization, optimization, scale-up, and troubleshooting
Comparability studies and change management
Technology transfer and knowledge management
Capacity planning studies and demand readiness
Raw and starting material selection, risk assessment, and qualification
Risk-based sample plan development
Stability program design and execution
Support Systems:
Quality system development and improvement for phase-appropriate GMPs
Quality Risk Management program development and risk assessment facilitation
Regulatory filing strategies and authoring
Contamination and cross contamination control strategy development and remediation support
Aseptic processing expertise and sterility assurance
Audit and inspection readiness and observation response
Specialty Consulting
Expert advice when you need it most. ValSource is available to help solve the complex issues surrounding regulatory expectations for control strategies and assist with regulatory communications beginning with initial developmental stages through commercialization.
ValSource consultants have unparalleled expertise to help navigate the complex regulatory environment of emerging therapeutics and delivery systems. We provide full services for key challenges including employing a science driven, risk-based approach to ensure success. Our consultants are widely known as thought leaders on ATMP and transdermal product development and manufacturing.