Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringEnsuring product quality, safety, and regulatory compliance with expert analytical services. Our integrated approach supports method development, validation, and quality control for cell and gene therapy products.
Our Services
Analytical Services
Reliable Data, Trusted Decisions, Successful Therapies
Reliable analytical data is essential for ensuring the safety, efficacy, and regulatory approval of cell and gene therapies. Without robust analytical methods, companies risk inconsistent results, regulatory challenges, and delays in product development.
Our Analytical Services team develops, validates, and implements cutting-edge analytical methods to support process development, batch release, and regulatory submissions. With expertise in advanced testing techniques and quality control, we ensure that the data generated is accurate, reproducible, and compliant with industry standards.
Our Analytical Capabilities
Our Analytical Services
Analytical Development
Developing robust and reliable analytical methods is crucial for supporting process development and regulatory submissions. Our team ensures that methods are fit for purpose, generating high-quality data that informs decision-making at every stage of therapy development. With expertise in NAT, qPCR, ddPCR, ELISA, Flow Cytometry, HPLC, DLS, spectrophotometry, and viral titration assays, we help clients establish validated approaches that support both research and GMP applications.
Process Development Data
Ensuring data accuracy and integrity is vital in process development studies, where analytical methods often require a high level of expertise and subjectivity. Our Analytical Services team provides independent testing using documented, validated procedures, recorded within our Electronic Laboratory Notebook (ELN) system. By implementing rigorous method controls and data validation processes, we ensure that all results meet the highest standards of reliability and reproducibility.
Quality Control
Stringent GMP-compliant Quality Control (QC) testing is essential for batch release, stability studies, and regulatory submissions. Our QC laboratories ensure data integrity and product consistency, using a validated Electronic Laboratory Notebook (ELN) system for transparency and compliance. Testing is performed under Good Manufacturing Practice (GMP) requirements and our Pharmaceutical Quality System (PQS) to maintain the highest quality standards. Whether conducting physiochemical, molecular, or biological testing, we ensure that every product meets its critical quality attributes before reaching patients.
Contract Services
As a MIA(IMP) licence holder, we provide contract testing services to support the manufacture of Advanced Therapeutic Investigational Medicinal Products (ATIMPs). This includes testing of intermediate products, bulk drug substances, final products, and stability samples. Our contract services ensure that manufacturing partners and clinical-stage developers receive the highest standard of analytical testing to support their product development and regulatory submissions.
Why Partner with Us?
Partner with Us for Expert Analytical Support
High-quality analytical data is the foundation of successful product development and regulatory approval. Whether developing new methods or ensuring GMP compliance, eXmoor Pharma provides expert analytical services tailored to your needs. Contact us today to discuss how our Analytical Services can support your therapy’s success.