Our Core team of principle consultants in Cell/Gene therapy is involved in every project. They leverage an extensive network of functional consultants/partners, allowing us to offer considerable expertise to satisfy each program needs.
We have consultants and technical support staff with the required backgrounds in regulatory affairs, quality management, process development and CMC for production of advance CGT products.
Our team of experienced managers and executives is dedicated to helping your organization navigate the complex landscape of Cell/Gene therapy program administration, operations, and compliance. We offer contract services for management, operations and quality assurance suitable to the scope and the size of your program.
Our experienced professionals have a deep understanding of the complex landscape of CGT production of clinical grade cellular therapy products. We offer a range of services to support our clients at every stage from early development to regulatory affairs and clinical applications.
Initial Consultation; Free
Review of Country specific regulations pertinent to production and clinical utility
Support Business Registration
Review of Applicable GTP/GMP Standards
Gap Analysis Pre-Accreditation
Business and Operational Plans Development
Facility design and qualification for GMP/GTP Cell therapy manufacturing
Staffing and training
Equipment selection and qualifications
Analytical methods development
Process Development/validation
Technology Transfer
Quality management system covering all core cell therapy GMP requirements
Products packaging and ISBT labeling
Products storage and stability studies
Documents development:/control: polices, procedures, agreements, INDs, and marketing materials
Accreditation readiness
Bioanalytical Testing
Quality Management, Assurance, and Support
Accreditation Renewal
Clinical Trial Design and INDs
Manufacturing Management
Continuous Improvement
Data Reporting
Let our experts evaluate, streamline, and enhance your clinical operations to achieve greater efficiency, compliance, and patient satisfaction. Whether you're building a new care model or refining your existing processes, we provide:
Your staff is your most valuable asset. NeoMedicine Partners helps you implement human resource strategies that support growth, retention, and regulatory compliance. Our consultants provide:
Harness Technology for Smarter Care Delivery.
From Electronic Health Records (EHRs) to data security, we help you align your IT infrastructure with your clinical and administrative goals. Our information systems team supports:
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